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American Ginseng to Improve HIV-Associated Fatigue: A Randomized, Placebo-Controlled, Parallel Design, Multiple-Dose Clinical Trial

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ClinicalTrials.gov Identifier: NCT01500096
Recruitment Status : Completed
First Posted : December 26, 2011
Results First Posted : June 12, 2018
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition HIV/AIDS-associated Fatigue
Interventions Drug: American ginseng
Dietary Supplement: Placebo for American ginseng
Enrollment 96
Recruitment Details Study participants were recruited from 2/13/13 through 10/19/15 from local HIV specialty clinics.
Pre-assignment Details Participants who met study criteria returned for an enrollment visit for randomization. Study drugs (placebo or ginseng) were dispensed by the Investigational Pharmacy. Participants were instructed to take study drugs daily for 28 days. They returned 2 wks after finishing taking study drugs for a final visit. No wash out or run-in periods.
Arm/Group Title American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day
Hide Arm/Group Description

4-week of American ginseng 1000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 1000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

4-week of American ginseng 3000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 3000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Period Title: Overall Study
Started 32 17 31 16
Completed 31 17 31 14
Not Completed 1 0 0 2
Reason Not Completed
Lost to Follow-up             1             0             0             2
Arm/Group Title American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day Total
Hide Arm/Group Description

4-week of American ginseng 1000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 1000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

4-week of American ginseng 3000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 3000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Total of all reporting groups
Overall Number of Baseline Participants 32 17 31 16 96
Hide Baseline Analysis Population Description
Participants took the study product daily for 28 days. Participants returned 2 weeks after finishing taking the study product for a final evaluation. All participants completed questionnaires to quantify fatigue, were assessed for adverse events, and laboratory tests including inflammatory markers.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants 17 participants 31 participants 16 participants 96 participants
51.8  (7.5) 52.1  (9.5) 53.7  (6.8) 50.2  (4.83) 52.2  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 17 participants 31 participants 16 participants 96 participants
Female
14
  43.8%
8
  47.1%
13
  41.9%
9
  56.3%
44
  45.8%
Male
18
  56.3%
9
  52.9%
18
  58.1%
7
  43.8%
52
  54.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 32 participants 17 participants 31 participants 16 participants 96 participants
32
 100.0%
17
 100.0%
31
 100.0%
16
 100.0%
96
 100.0%
1.Primary Outcome
Title Change in Fatigue Severity Score (FSS)
Hide Description Change in FSS score from baseline to Week 4. The change in fatigue as measured by the FSS (Week 4 minus Baseline) using the Wilcoxon test. The FSS is a scale score ranging from 1 to 63 with higher scores indicative of more fatigue. A negative number indicates a decline in the FSS scale. Participants with FSS data at both times points were assessed.
Time Frame From baseline to week 4 (28 days of study drugs)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was one missing scale from the ginseng 3000 arm
Arm/Group Title American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day
Hide Arm/Group Description:

4-week of American ginseng 1000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 1000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

4-week of American ginseng 3000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 3000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Overall Number of Participants Analyzed 31 17 30 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
-24.7  (18.6) -16.3  (18.6) -16.9  (15) -21.6  (16.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection American Ginseng 1000 mg/Day, Placebo for American Ginseng 1000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for American Ginseng 1000 mg/Day, American Ginseng 3000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.73
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
2.Secondary Outcome
Title Change in the Brief Fatigue Inventory
Hide Description Questionnaire: Change in the Brief Fatigue Inventory (BFI) from baseline to week 4. We compared BFI scores from baseline to week 4 in the ginseng 1000 and 3000 mg arms with the combined placebo arms. We used the BFI Question that assess "Worst Fatigue" score: 0 to 90 scale. Higher scores means more fatigue; negative values mean less fatigue.The BFI was used to supplement the data obtained from the FSS.
Time Frame Change in BFI scores from baseline to week 4 (28 days of study drugs)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was on missing questionnaire from the ginseng 3000 arm
Arm/Group Title American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day
Hide Arm/Group Description:

4-week of American ginseng 1000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 1000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

4-week of American ginseng 3000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 3000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Overall Number of Participants Analyzed 31 17 30 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
-44.2  (34.3) -26.5  (28.5) -42.7  (32.4) -37.9  (35.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection American Ginseng 1000 mg/Day, Placebo for American Ginseng 1000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1329
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for American Ginseng 1000 mg/Day, American Ginseng 3000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1191
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
3.Secondary Outcome
Title Change in Epworth Sleepiness Scale
Hide Description Questionnaire: Change in Epworth Sleepiness Scale (ESS) score from baseline to week 4. The ESS is scale ranges from 0 to 24; higher scores mean worse sleep disorder while a negative score indicates less sleep disorder. The ESS was used to supplement the data obtained from the FSS.
Time Frame From baseline to week 4 (28 days of study drugs)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was one missing questionnaire from the ginseng 3000 arm
Arm/Group Title American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day
Hide Arm/Group Description:

4-week of American ginseng 1000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 1000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

4-week of American ginseng 3000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 3000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Overall Number of Participants Analyzed 31 17 30 14
Mean (Standard Error)
Unit of Measure: units on a scale
-5.74  (7.15) -6.35  (4.43) -6.97  (5.23) -5.93  (3.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection American Ginseng 1000 mg/Day, Placebo for American Ginseng 1000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7454
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for American Ginseng 1000 mg/Day, American Ginseng 3000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7391
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
4.Secondary Outcome
Title Change in Patient Health Questionnaire 9
Hide Description Questionnaire: Change in Patient Health Questionnaire 9 (PHQ9) score from baseline to week 4. The scale for the PHQ9 score ranges from 0 to 27; higher scores mean worse depression; negative scores indicate less depression. We compared PHQ 9 scores from baseline to week 4 in the ginseng 1000 and 3000 mg arms with the combined placebo arms. The PHQ9 was used to supplement the data obtained from the FSS.
Time Frame From baseline to week 4 (28 days of study drugs)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was one missed PHQ9 in the ginseng 3000 mg arm
Arm/Group Title American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day
Hide Arm/Group Description:

4-week of American ginseng 1000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 1000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

4-week of American ginseng 3000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 3000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Overall Number of Participants Analyzed 31 17 30 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.52  (4.76) -5.59  (4.84) -2.87  (4.20) -3.86  (3.16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection American Ginseng 1000 mg/Day, Placebo for American Ginseng 1000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6818
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for American Ginseng 1000 mg/Day, American Ginseng 3000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0579
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
5.Secondary Outcome
Title Change in Insomnia Severity Index
Hide Description Questionnaire: Change in Insomnia Severity Index (ISI) score from baseline to week 4. The ISI scale ranges from 0 to 28; higher scores mean worse insomnia while negative scores indicate less insomnia. The ISI was used to supplement the data obtained from the FSS.
Time Frame From baseline to week 4 (28 days of study drugs)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was one missing ISI in the ginseng 3000 mg arm
Arm/Group Title American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day
Hide Arm/Group Description:

4-week of American ginseng 1000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 1000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

4-week of American ginseng 3000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 3000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Overall Number of Participants Analyzed 31 17 30 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.9  (6.07) -5.47  (5.15) -3.43  (5.49) -3.57  (5.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection American Ginseng 1000 mg/Day, Placebo for American Ginseng 1000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for American Ginseng 1000 mg/Day, American Ginseng 3000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
6.Secondary Outcome
Title Change in Medical Outcomes Study HIV Health Survey
Hide Description Questionnaire: Change in Medical Outcomes Study (MOS) HIV Health Survey score from baseline to week 4. We evaluated the MOS Energy Fatigue scores; the MOS scale ranges from 0-100; higher scores mean more energy. The MOS was used to supplement the data obtained from the FSS.
Time Frame From baseline to week 4 (28 days of study drugs)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day
Hide Arm/Group Description:

4-week of American ginseng 1000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 1000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

4-week of American ginseng 3000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 3000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Overall Number of Participants Analyzed 31 17 31 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
22.4  (20.9) 17.6  (19.5) 24.0  (22.0) 23.1  (21.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection American Ginseng 1000 mg/Day, Placebo for American Ginseng 1000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7884
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for American Ginseng 1000 mg/Day, American Ginseng 3000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5532
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
7.Secondary Outcome
Title Changes in Clinical Global Impressions
Hide Description Questionnaire: Change in Clinical Global Impressions (CGI) scores from baseline to week 4. CGI is an instrument for making global assessments of worsening or improvement during interventional trials. The subject rates the change in the overall status since beginning the intervention (ranging from: very much improved, much improved, minimally improved, no change, and minimally worse). We assessed the number of participants who rated "very much improved".
Time Frame From baseline to week 4 (28 days of study drugs)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day
Hide Arm/Group Description:

4-week of American ginseng 1000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 1000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

4-week of American ginseng 3000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 3000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Overall Number of Participants Analyzed 31 17 31 14
Measure Type: Count of Participants
Unit of Measure: Participants
3
   9.7%
3
  17.6%
7
  22.6%
0
   0.0%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection American Ginseng 1000 mg/Day, Placebo for American Ginseng 1000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9885
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for American Ginseng 1000 mg/Day, American Ginseng 3000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2898
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sides Wilcoxon (Mann-Whitney)
8.Secondary Outcome
Title Inflammatory Markers
Hide Description Laboratory - Inflammatory Markers (IMs): Change in Interleukin (IL) -6 and soluble receptors of tumor necrosis factor (TNF) α 1 and 2 (sTNFR1 and sTNFR2) from baseline to week 4. Negative values indicate less change in inflammatory markers.
Time Frame From baseline to week 4 (28 days of study drugs)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day
Hide Arm/Group Description:

4-week of American ginseng 1000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 1000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

4-week of American ginseng 3000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 3000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Overall Number of Participants Analyzed 31 17 31 14
Mean (Standard Deviation)
Unit of Measure: pg/ml
IL-6 0.22  (1.18) 0.53  (1.99) 0.079  (1.63) 0.33  (1.33)
sTNFR1 19.5  (135.5) -15.5  (154.5) 15.2  (170.5) -6.24  (142)
sTNFR2 183.5  (667.9) 4.08  (580.5) -207.7  (1156.1) -201.7  (1156.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection American Ginseng 1000 mg/Day, Placebo for American Ginseng 1000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the IL-6 level changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for American Ginseng 1000 mg/Day, American Ginseng 3000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the IL-6 level changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection American Ginseng 1000 mg/Day, Placebo for American Ginseng 1000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the sTNFR1 level changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo for American Ginseng 1000 mg/Day, American Ginseng 3000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the sTNFR1 level changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection American Ginseng 1000 mg/Day, Placebo for American Ginseng 1000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the sTNFR2 level changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo for American Ginseng 1000 mg/Day, American Ginseng 3000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the sTNFR2 level changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.58
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
9.Secondary Outcome
Title Change in CD4 Cell Count
Hide Description Laboratory: Change in absolute cluster of differentiation 4 (CD4) cell count from baseline to week 5. Negative values mean decline in CD4 cell count.
Time Frame From baseline to week 5 (28 days of study drugs)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day
Hide Arm/Group Description:

4-week of American ginseng 1000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 1000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

4-week of American ginseng 3000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 3000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Overall Number of Participants Analyzed 31 17 31 14
Mean (Standard Deviation)
Unit of Measure: cells per cubic millimeter
3.45  (111.5) 56.6  (147.5) -23.1  (148.4) 34.4  (99.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection American Ginseng 1000 mg/Day, Placebo for American Ginseng 1000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 5 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for American Ginseng 1000 mg/Day, American Ginseng 3000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.71
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
10.Secondary Outcome
Title Change in Plasma HIV RNA
Hide Description Laboratory: Change in plasma HIV RNA from baseline to week 4. A negative value means a drop in plasma HIV RNA.
Time Frame From baseline to week 4 (28 days of study drugs)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day
Hide Arm/Group Description:

4-week of American ginseng 1000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 1000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

4-week of American ginseng 3000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 3000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Overall Number of Participants Analyzed 31 17 31 14
Mean (Standard Deviation)
Unit of Measure: copies/mL
1.94  (6.19) -0.06  (4.78) 1.32  (7.02) 0.0  (0.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection American Ginseng 1000 mg/Day, Placebo for American Ginseng 1000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for American Ginseng 1000 mg/Day, American Ginseng 3000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
11.Secondary Outcome
Title Change in PROMIS Fatigue
Hide Description Questionnaire: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue score from baseline to week 4. Change in PROMIS fatigue score from baseline to Week 4. The change in fatigue as measured by the PROMIS fatigue (Week 4 minus Baseline) using the Wilcoxon test. The PROMIS fatigue is a scale with normalized mean of 50 and standard deviation (SD) of 10. Higher mean values mean more fatigue and negative values indicate less fatigue.
Time Frame From baseline to week 4 (28 days of study drugs).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There was one missed PROMIS fatigue questionnaire in the ginseng 3000 mg arm.
Arm/Group Title American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day
Hide Arm/Group Description:

4-week of American ginseng 1000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 1000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

4-week of American ginseng 3000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 3000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Overall Number of Participants Analyzed 31 17 30 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
-12.5  (11.8) -11.1  (11.0) -11.4  (10.9) -9.49  (11.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection American Ginseng 1000 mg/Day, Placebo for American Ginseng 1000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.47
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo for American Ginseng 1000 mg/Day, American Ginseng 3000 mg/Day, Placebo for American Ginseng 3000 mg/Day
Comments Testing whether the changes from baseline to week 4 are significantly different between arms.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments 2 sided Wilcoxon (Mann-Whitney)
12.Secondary Outcome
Title Number of Participants With Adverse Events in the Ginseng and Placebo Arms
Hide Description Adverse events (AEs) were assessed from baseline to wk 4 using the NIH Division of AIDS (DAIDS) Grading Toxicity Table, a well known tool used by NIH networks for assessing the severity of AEs in participants enrolled in clinical trials. Reporting the number of participants in each arm who experienced adverse events.
Time Frame From baseline to week 4 (28 days of study drugs)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day
Hide Arm/Group Description:

4-week of American ginseng 1000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 1000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

4-week of American ginseng 3000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 3000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

Overall Number of Participants Analyzed 32 17 31 16
Measure Type: Count of Participants
Unit of Measure: Participants
30
  93.8%
16
  94.1%
31
 100.0%
13
  81.3%
Time Frame 4 weeks
Adverse Event Reporting Description The NIH Division of AIDS Toxicity table was used to grade averse event severity for this clinical trial. Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe), Grade 4 (Potentially Life Threatening), Grade 5 (Death). Some data was lost and is no longer available for 1 participant in the Ginseng 1000 mg/day arm, and 2 participants in the Placebo for the Ginseng 3000 mg/Day arm.
 
Arm/Group Title American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day
Hide Arm/Group Description

4-week of American ginseng 1000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 1000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

4-week of American ginseng 3000 mg/day every morning

American ginseng: American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

4-week of placebo for American ginseng 3000 mg/day every morning

Placebo for American ginseng: Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.

Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day

All-Cause Mortality
American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)      0/17 (0.00%)      0/31 (0.00%)      0/16 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/32 (6.25%)      2/17 (11.76%)      4/31 (12.90%)      2/16 (12.50%)    
General disorders         
Pain Right Index Finger  1 [1]  0/32 (0.00%)  0 0/17 (0.00%)  0 1/31 (3.23%)  1 0/16 (0.00%)  0
Abdominal Pain  1 [2]  0/32 (0.00%)  0 0/17 (0.00%)  0 0/31 (0.00%)  0 1/16 (6.25%)  1
Right Flank Pain  1 [3]  0/32 (0.00%)  0 0/17 (0.00%)  0 0/31 (0.00%)  0 1/16 (6.25%)  1
Hepatobiliary disorders         
Increased AST  1 [4]  0/32 (0.00%)  0 0/17 (0.00%)  0 1/31 (3.23%)  1 0/16 (0.00%)  0
Immune system disorders         
Low ANC  1 [5]  1/32 (3.13%)  1 1/17 (5.88%)  1 0/31 (0.00%)  0 1/16 (6.25%)  1
Infections and infestations         
Cellulitis  1 [6]  0/32 (0.00%)  0 1/17 (5.88%)  1 1/31 (3.23%)  1 0/16 (0.00%)  0
Metabolism and nutrition disorders         
Hyperglycemia  1 [7]  0/32 (0.00%)  0 0/17 (0.00%)  0 0/31 (0.00%)  0 0/16 (0.00%)  0
Renal and urinary disorders         
Kidney Stone  1 [8]  0/32 (0.00%)  0 0/17 (0.00%)  0 0/31 (0.00%)  0 1/16 (6.25%)  1
Ureterolithiasis  1 [9]  0/32 (0.00%)  0 0/17 (0.00%)  0 0/31 (0.00%)  0 1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders         
Bronchitis  1 [10]  1/32 (3.13%)  1 0/17 (0.00%)  0 0/31 (0.00%)  0 0/16 (0.00%)  0
Surgical and medical procedures         
Hip Replacement  1 [11]  0/32 (0.00%)  0 0/17 (0.00%)  0 1/31 (3.23%)  1 0/16 (0.00%)  0
1
Term from vocabulary, DAIDS Toxicity Table
Indicates events were collected by systematic assessment
[1]
Pain Right Index Finger
[2]
Abdominal Pain
[3]
Right Flank Pain
[4]
Increased Aspartate aminotransferase (AST)
[5]
Low Absolute Neutrophil Count (ANC)
[6]
Cellulitis Right Finger
[7]
Hyperglycemia
[8]
Kidney Stone
[9]
Ureterolithiasis
[10]
Bronchitis
[11]
Right Hip Replacement
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
American Ginseng 1000 mg/Day Placebo for American Ginseng 1000 mg/Day American Ginseng 3000 mg/Day Placebo for American Ginseng 3000 mg/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/32 (93.75%)      16/17 (94.12%)      31/31 (100.00%)      13/16 (81.25%)    
Blood and lymphatic system disorders         
Decreased ANC  1 [1]  5/32 (15.63%)  5 3/17 (17.65%)  3 5/31 (16.13%)  5 3/16 (18.75%)  3
Cardiac disorders         
Hypertension  1 [2]  3/32 (9.38%)  3 2/17 (11.76%)  2 1/31 (3.23%)  1 0/16 (0.00%)  0
Endocrine disorders         
Hyperglycemia  1 [3]  5/32 (15.63%)  5 4/17 (23.53%)  4 8/31 (25.81%)  8 4/16 (25.00%)  4
Gastrointestinal disorders         
Diarrhea  1 [4]  1/32 (3.13%)  1 0/17 (0.00%)  0 3/31 (9.68%)  3 1/16 (6.25%)  1
Nausea  1 [5]  6/32 (18.75%)  6 6/17 (35.29%)  6 7/31 (22.58%)  9 5/16 (31.25%)  9
General disorders         
Fatigue  1 [6]  1/32 (3.13%)  1 0/17 (0.00%)  0 2/31 (6.45%)  2 2/16 (12.50%)  2
Hepatobiliary disorders         
Elevated ALT  1 [7]  7/32 (21.88%)  7 3/17 (17.65%)  3 6/31 (19.35%)  6 3/16 (18.75%)  3
Elevated AST  1 [8]  8/32 (25.00%)  8 4/17 (23.53%)  4 6/31 (19.35%)  6 4/16 (25.00%)  4
Elevated Alkaline Phosphatase  1 [9]  4/32 (12.50%)  4 4/17 (23.53%)  4 4/31 (12.90%)  4 1/16 (6.25%)  1
Elevated Bilirubin  1 [10]  6/32 (18.75%)  6 1/17 (5.88%)  1 1/31 (3.23%)  1 2/16 (12.50%)  2
Infections and infestations         
Upper Respiratory Infection  1 [11]  4/32 (12.50%)  4 1/17 (5.88%)  1 1/31 (3.23%)  1 2/16 (12.50%)  2
Metabolism and nutrition disorders         
Decreased Potassium  1  1/32 (3.13%)  1 4/17 (23.53%)  4 0/31 (0.00%)  0 3/16 (18.75%)  3
Elevated Glucose  1 [12]  1/32 (3.13%)  1 2/17 (11.76%)  2 4/31 (12.90%)  4 3/16 (18.75%)  3
Nervous system disorders         
Diziness  1 [13]  11/32 (34.38%)  12 7/17 (41.18%)  7 6/31 (19.35%)  6 5/16 (31.25%)  5
Headache  1 [14]  11/32 (34.38%)  13 9/17 (52.94%)  10 7/31 (22.58%)  14 5/16 (31.25%)  7
Insomnia  1 [15]  11/32 (34.38%)  17 9/17 (52.94%)  9 7/31 (22.58%)  18 5/16 (31.25%)  5
Nervousness  1 [16]  9/32 (28.13%)  9 6/17 (35.29%)  6 5/31 (16.13%)  5 5/16 (31.25%)  5
Psychiatric disorders         
anxiety  1 [17]  11/32 (34.38%)  11 9/17 (52.94%)  9 7/31 (22.58%)  7 5/16 (31.25%)  5
Renal and urinary disorders         
Elevated Creatinine  1 [18]  0/32 (0.00%)  0 0/17 (0.00%)  0 5/31 (16.13%)  5 1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders         
cough  1 [19]  3/32 (9.38%)  3 1/17 (5.88%)  1 0/31 (0.00%)  0 1/16 (6.25%)  1
1
Term from vocabulary, DAIDS Toxicity Table
Indicates events were collected by systematic assessment
[1]
Decreased ANC
[2]
Hypertension
[3]
Hyperglycemia
[4]
Diarrhea
[5]
Nausea
[6]
Fatigue
[7]
Elevated Alanine Aminotransferase (ALT)
[8]
Elevated AST
[9]
Elevated Alkaline Phosphatase
[10]
Elevated Bilirubin
[11]
Upper Respiratory Infection
[12]
Elevated Glucose
[13]
Dizziness
[14]
Headache
[15]
Insomnia
[16]
Nervousness
[17]
Anxiety
[18]
Elevated Creatinine
[19]
Cough
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Adriana Andrade
Organization: Johns Hokpins University
Phone: 410-955-7287
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01500096     History of Changes
Other Study ID Numbers: NA_00071671
First Submitted: December 14, 2011
First Posted: December 26, 2011
Results First Submitted: February 5, 2018
Results First Posted: June 12, 2018
Last Update Posted: July 10, 2018