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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study participants were recruited from 2/13/13 through 10/19/15 from local HIV specialty clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
American Ginseng 1000 mg/Day

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.

Placebo for American Ginseng 1000 mg/Day

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

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.

Placebo for American Ginseng 3000 mg/Day

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


Participant Flow:   Overall Study
    American Ginseng 1000 mg/Day   Placebo for American Ginseng 1000 mg/Day   American Ginseng 3000 mg/Day   Placebo for American Ginseng 3000 mg/Day
STARTED   32   17   31   16 
COMPLETED   31   17   31   14 
NOT COMPLETED   1   0   0   2 
Lost to Follow-up                1                0                0                2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups
  Description
American Ginseng 1000 mg/Day

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.

Placebo for American Ginseng 1000 mg/Day

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

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.

Placebo for American Ginseng 3000 mg/Day

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 Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 32   17   31   16   96 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.8  (7.5)   52.1  (9.5)   53.7  (6.8)   50.2  (4.83)   52.2  (7.3) 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
         
United States   32   17   31   16   96 


  Outcome Measures

1.  Primary:   Change in Fatigue Severity Score (FSS)   [ Time Frame: From baseline to week 4 (28 days of study drugs) ]

2.  Secondary:   Change in the Brief Fatigue Inventory   [ Time Frame: Change in BFI scores from baseline to week 4 (28 days of study drugs) ]

3.  Secondary:   Change in Epworth Sleepiness Scale   [ Time Frame: From baseline to week 4 (28 days of study drugs) ]

4.  Secondary:   Change in Patient Health Questionnaire 9   [ Time Frame: From baseline to week 4 (28 days of study drugs) ]

5.  Secondary:   Change in Insomnia Severity Index   [ Time Frame: From baseline to week 4 (28 days of study drugs) ]

6.  Secondary:   Change in Medical Outcomes Study HIV Health Survey   [ Time Frame: From baseline to week 4 (28 days of study drugs) ]

7.  Secondary:   Changes in Clinical Global Impressions   [ Time Frame: From baseline to week 4 (28 days of study drugs) ]

8.  Secondary:   Inflammatory Markers   [ Time Frame: From baseline to week 4 (28 days of study drugs) ]

9.  Secondary:   Change in CD4 Cell Count   [ Time Frame: From baseline to week 5 (28 days of study drugs) ]

10.  Secondary:   Change in Plasma HIV RNA   [ Time Frame: From baseline to week 4 (28 days of study drugs) ]

11.  Secondary:   Change in PROMIS Fatigue   [ Time Frame: From baseline to week 4 (28 days of study drugs). ]

12.  Secondary:   Number of Participants With Adverse Events in the Ginseng and Placebo Arms   [ Time Frame: From baseline to week 4 (28 days of study drugs) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: aandrade@jhmi.edu


Publications:

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