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American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL

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ClinicalTrials.gov Identifier: NCT00752895
Recruitment Status : Completed
First Posted : September 16, 2008
Results First Posted : November 2, 2015
Last Update Posted : September 11, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Leukemia
Interventions Dietary Supplement: American ginseng
Dietary Supplement: Placebo
Enrollment 293

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I - Ginseng Arm II - Placebo
Hide Arm/Group Description

Patients receive oral American ginseng extract twice daily.

American ginseng: Given orally

Patients receive oral placebo twice daily.

Placebo: Given orally

Period Title: Overall Study
Started 147 146
Completed 139 143
Not Completed 8 3
Reason Not Completed
Withdrawal by Subject             8             3
Arm/Group Title Arm I - Ginseng Arm II - Placebo Total
Hide Arm/Group Description

Patients receive oral American ginseng extract twice daily.

American ginseng: Given orally

Patients receive oral placebo twice daily.

Placebo: Given orally

Total of all reporting groups
Overall Number of Baseline Participants 147 146 293
Hide Baseline Analysis Population Description
All randomized participants
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 146 participants 293 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
71
  48.3%
64
  43.8%
135
  46.1%
>=65 years
76
  51.7%
82
  56.2%
158
  53.9%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 147 participants 146 participants 293 participants
65
(43 to 87)
66
(44 to 82)
65
(43 to 87)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 146 participants 293 participants
Female
65
  44.2%
60
  41.1%
125
  42.7%
Male
82
  55.8%
86
  58.9%
168
  57.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 146 participants 293 participants
Hispanic or Latino
0
   0.0%
2
   1.4%
2
   0.7%
Not Hispanic or Latino
147
 100.0%
144
  98.6%
291
  99.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 147 participants 146 participants 293 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   0.7%
1
   0.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   1.4%
3
   2.1%
5
   1.7%
White
145
  98.6%
141
  96.6%
286
  97.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   0.7%
1
   0.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 147 participants 146 participants 293 participants
147 146 293
1.Primary Outcome
Title Acute Respiratory Infection (ARI) Days
Hide Description An ARI day was defined as any day for which the subject experienced one or more respiratory symptoms (cough, sore throat, nasal or sinus congestion, or runny nose) and one or more systemic symptoms (feverishness, chills/sweats, myalgia (muscle aches), fatigue, headache, poor endurance or increased shortness of breath) between January and March.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who returned a respiratory symptom diary between January and March. Note that a few participants failed to provide respiratory diaries so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with adverse event data.
Arm/Group Title Arm I - Ginseng Arm II - Placebo
Hide Arm/Group Description:

Patients receive oral American ginseng extract twice daily.

American ginseng: Given orally

Patients receive oral placebo twice daily.

Placebo: Given orally

Overall Number of Participants Analyzed 137 143
Mean (Standard Deviation)
Unit of Measure: days
8.30  (16.87) 6.78  (13.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I - Ginseng, Arm II - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.295
Comments This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.
Method Negative binomial regression
Comments [Not Specified]
2.Secondary Outcome
Title Number of Antibiotic Use Days
Hide Description An antibiotic day was defined as a day on which the subject took one or more antibiotics between January and March.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who returned respiratory symptom and antibiotic use diaries. Note that a few participants failed to provide antibiotic use diaries so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with adverse event data.
Arm/Group Title Arm I - Ginseng Arm II - Placebo
Hide Arm/Group Description:

Patients receive oral American ginseng extract twice daily.

American ginseng: Given orally

Patients receive oral placebo twice daily.

Placebo: Given orally

Overall Number of Participants Analyzed 137 143
Mean (Standard Deviation)
Unit of Measure: days
1.12  (3.42) 1.55  (6.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I - Ginseng, Arm II - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.820
Comments This p-value is not adjusted for multiple comparisons. The a priori threshold for statistical significance was 0.05.
Method Negative binomial regression
Comments [Not Specified]
Time Frame 5 months
Adverse Event Reporting Description Note that some participants had adverse events and later dropped out so the numbers of participants for these analyses do not necessarily match the numbers who remained in the study or the numbers with primary outcome data.
 
Arm/Group Title Arm I - Ginseng Arm II - Placebo
Hide Arm/Group Description

Patients receive oral American ginseng extract twice daily.

American ginseng: Given orally

Patients receive oral placebo twice daily.

Placebo: Given orally

All-Cause Mortality
Arm I - Ginseng Arm II - Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I - Ginseng Arm II - Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/140 (7.86%)      16/143 (11.19%)    
Blood and lymphatic system disorders     
Hemolysis  1  0/140 (0.00%)  0 1/143 (0.70%)  1
Platelets (160-360)  1  0/140 (0.00%)  0 1/143 (0.70%)  3
Cardiac disorders     
Cardiac ischemia/fnfarction  1  1/140 (0.71%)  1 2/143 (1.40%)  2
Hypertension  1  1/140 (0.71%)  2 0/143 (0.00%)  0
Hypotension  1  0/140 (0.00%)  0 1/143 (0.70%)  1
Supraventricular and nodal arrhythmia: Sinus Bradycardia  1  1/140 (0.71%)  1 0/143 (0.00%)  0
Syncope (fainting)  1  1/140 (0.71%)  1 0/143 (0.00%)  0
Ventricular Arrhythmia NOS  1  1/140 (0.71%)  1 0/143 (0.00%)  0
Ear and labyrinth disorders     
Dizziness  1  1/140 (0.71%)  1 0/143 (0.00%)  0
Gastrointestinal disorders     
Diarrhea  1  1/140 (0.71%)  1 0/143 (0.00%)  0
Diarrhea - without colostomy  1  1/140 (0.71%)  1 0/143 (0.00%)  0
Hemorrhage, GI: Peritoneal cavity  1  0/140 (0.00%)  0 1/143 (0.70%)  1
Vomiting  1  0/140 (0.00%)  0 1/143 (0.70%)  1
General disorders     
Pain: Abdomen NOS  1  0/140 (0.00%)  0 3/143 (2.10%)  4
Pain: Back  1  0/140 (0.00%)  0 1/143 (0.70%)  1
Pain: Chest Wall  1  0/140 (0.00%)  0 2/143 (1.40%)  2
Pain: Chest/thorax NOS  1  0/140 (0.00%)  0 1/143 (0.70%)  1
Pain:Stomach  1  0/140 (0.00%)  0 1/143 (0.70%)  1
Infections and infestations     
Infection with Grade 3/4 ANC: Skin  1  0/140 (0.00%)  0 1/143 (0.70%)  1
Infection with normal ANC or grade 1/2 neutrophils: Lung (pneumonia)  1  1/140 (0.71%)  1 0/143 (0.00%)  0
Infection with normal ANC or Grade 1/2 neutrophils: Spleen  1  0/140 (0.00%)  0 1/143 (0.70%)  2
Infection with unknown ANC: upper airway NOS  1  0/140 (0.00%)  0 1/143 (0.70%)  1
Infection with unknown ANC: Brain (encephalitis)  1  1/140 (0.71%)  1 0/143 (0.00%)  0
Metabolism and nutrition disorders     
Hypercalcemia  1  1/140 (0.71%)  1 0/143 (0.00%)  0
Hyperglycemia  1  1/140 (0.71%)  1 2/143 (1.40%)  2
Musculoskeletal and connective tissue disorders     
Pain - Joint  1  1/140 (0.71%)  3 3/143 (2.10%)  5
Nervous system disorders     
Headache  1  0/140 (0.00%)  0 1/143 (0.70%)  1
Seizure  1  1/140 (0.71%)  1 0/143 (0.00%)  0
Renal and urinary disorders     
Urinary Frequency / Urgency  1  1/140 (0.71%)  1 0/143 (0.00%)  0
Urinary Frequency / Urgency - Pllakiuria  1  1/140 (0.71%)  1 0/143 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Bronchospasm, wheezing  1  0/140 (0.00%)  0 1/143 (0.70%)  1
Dyspnea  1  2/140 (1.43%)  2 2/143 (1.40%)  2
Pleural Effusion (non-malignant)  1  0/140 (0.00%)  0 1/143 (0.70%)  1
Skin and subcutaneous tissue disorders     
Rash/Desquamation  1  0/140 (0.00%)  0 1/143 (0.70%)  1
Ulceration  1  0/140 (0.00%)  0 1/143 (0.70%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I - Ginseng Arm II - Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   121/140 (86.43%)      126/143 (88.11%)    
Cardiac disorders     
Hypertension  1  21/140 (15.00%)  34 23/143 (16.08%)  37
Gastrointestinal disorders     
Diarrhea - without colostomy  1  15/140 (10.71%)  22 19/143 (13.29%)  25
Heartburn  1  27/140 (19.29%)  46 36/143 (25.17%)  57
Nausea  1  8/140 (5.71%)  9 14/143 (9.79%)  18
Vomiting  1  4/140 (2.86%)  4 8/143 (5.59%)  8
General disorders     
Hemorrhage, Nose - Epistaxis  1  3/140 (2.14%)  4 11/143 (7.69%)  15
Metabolism and nutrition disorders     
Hyperglycemia  1  32/140 (22.86%)  56 44/143 (30.77%)  70
Musculoskeletal and connective tissue disorders     
Pain - Joint  1  57/140 (40.71%)  110 65/143 (45.45%)  123
Nervous system disorders     
Dizziness  1  17/140 (12.14%)  27 18/143 (12.59%)  24
Headache  1  38/140 (27.14%)  58 39/143 (27.27%)  63
Neurology - Other - Nervousness  1  18/140 (12.86%)  22 11/143 (7.69%)  15
Psychiatric disorders     
Insomnia  1  55/140 (39.29%)  85 36/143 (25.17%)  63
Renal and urinary disorders     
Urinary Frequency / Urgency - Pllakiuria  1  40/140 (28.57%)  77 33/143 (23.08%)  54
Skin and subcutaneous tissue disorders     
Rash / Desquamation  1  6/140 (4.29%)  6 13/143 (9.09%)  20
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Doug Case
Organization: Wake Forest NCORP Research Base
Phone: (336) 716-1048
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00752895     History of Changes
Other Study ID Numbers: IRB00006819
U10CA081851 ( U.S. NIH Grant/Contract )
REBACCCWFU98308 ( Other Identifier: NCI )
First Submitted: September 13, 2008
First Posted: September 16, 2008
Results First Submitted: September 28, 2015
Results First Posted: November 2, 2015
Last Update Posted: September 11, 2018