A Phase 2 interventional study of American ginseng and Placebo in Leukemia, sponsored by Wake Forest University Health Sciences. Completed at 125 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-28.
Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Prevention
RATIONALE: American ginseng extract may prevent or reduce acute respiratory illness in patients with chronic lymphocytic leukemia. It is not yet known whether American ginseng extract is more effective than a placebo in preventing respiratory infections.
PURPOSE: This randomized trial is studying the side effects of American ginseng extract and to see how well it works compared with a placebo in preventing respiratory infection and in reducing antibiotic use in patients with chronic lymphocytic leukemia.
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter study. Patients are stratified according to antibiotic prophylaxis with trimethoprim-sulfamethoxazole (yes vs no), serum IgG (≤ 500 mg/dL vs > 500 mg/dL), and influenza vaccine status (yes vs no). Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed at 4 weeks by phone.
1,031 studies on the registry are indexed under Respiratory Tract Infections; 144 are open to participants now.
This study's enrollment of 293 is above the median of 199 across 698 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of chronic lymphocytic leukemia (CLL)
PATIENT CHARACTERISTICS:
No other prior or concurrent malignancies except for non-melanoma skin cancers or carcinoma in situ of the cervix
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Patients receive oral American ginseng extract twice daily.
Dietary Supplement: American ginseng
Patients receive oral placebo twice daily.
Dietary Supplement: Placebo
Given orally
Given orally
Acute Respiratory Infection (ARI) Days
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
Number of Antibiotic Use Days
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
| Milestone | Arm I - Ginseng | Arm II - Placebo |
|---|---|---|
| Started | 147 | 146 |
| Completed | 139 | 143 |
| Not completed | 8 | 3 |
| Withdrew: Withdrawal by subject | 8 | 3 |
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.
| days | Arm I - Ginseng | Arm II - Placebo |
|---|---|---|
| Acute Respiratory Infection (ARI) Days | 8.30 ± 16.87 | 6.78 ± 13.27 |
An antibiotic day was defined as a day on which the subject took one or more antibiotics between January and March.
| days | Arm I - Ginseng | Arm II - Placebo |
|---|---|---|
| Number of Antibiotic Use Days | 1.12 ± 3.42 | 1.55 ± 6.46 |
Collected over 5 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm I - Ginseng | — | 11/140 (7.9%) | 121/140 (86.4%) |
| Arm II - Placebo | — | 16/143 (11.2%) | 126/143 (88.1%) |
| Event | Arm I - Ginseng | Arm II - Placebo |
|---|---|---|
| Pain - JointMusculoskeletal and connective tissue disorders | 1/140 | 3/143 |
| Pain: Abdomen NOSGeneral disorders | 0/140 | 3/143 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/140 | 2/143 |
| Cardiac ischemia/fnfarctionCardiac disorders | 1/140 | 2/143 |
| HyperglycemiaMetabolism and nutrition disorders | 1/140 | 2/143 |
| Pain: Chest WallGeneral disorders | 0/140 | 2/143 |
| HypercalcemiaMetabolism and nutrition disorders | 1/140 | 0/143 |
| DiarrheaGastrointestinal disorders | 1/140 | 0/143 |
| Diarrhea - without colostomyGastrointestinal disorders | 1/140 | 0/143 |
| DizzinessEar and labyrinth disorders | 1/140 | 0/143 |
| Event | Arm I - Ginseng | Arm II - Placebo |
|---|---|---|
| Pain - JointMusculoskeletal and connective tissue disorders | 57/140 | 65/143 |
| InsomniaPsychiatric disorders | 55/140 | 36/143 |
| HyperglycemiaMetabolism and nutrition disorders | 32/140 | 44/143 |
| Urinary Frequency / Urgency - PllakiuriaRenal and urinary disorders | 40/140 | 33/143 |
| HeadacheNervous system disorders | 38/140 | 39/143 |
| HeartburnGastrointestinal disorders | 27/140 | 36/143 |
| HypertensionCardiac disorders | 21/140 | 23/143 |
| Diarrhea - without colostomyGastrointestinal disorders | 15/140 | 19/143 |
| Neurology - Other - NervousnessNervous system disorders | 18/140 | 11/143 |
| DizzinessNervous system disorders | 17/140 | 18/143 |
All randomized participants
| Age, Categorical(Participants) | Arm I - Ginseng | Arm II - Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 71 | 64 | 135 |
| >=65 years | 76 | 82 | 158 |
| Age, Continuous(years) | Arm I - Ginseng | Arm II - Placebo | Total |
|---|---|---|---|
| Median | 65 (43 to 87) | 66 (44 to 82) | 65 (43 to 87) |
| Sex: Female, Male(Participants) | Arm I - Ginseng | Arm II - Placebo | Total |
|---|---|---|---|
| Female | 65 | 60 | 125 |
| Male | 82 | 86 | 168 |
| Ethnicity (NIH/OMB)(Participants) | Arm I - Ginseng | Arm II - Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 147 | 144 | 291 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm I - Ginseng | Arm II - Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 3 | 5 |
| White | 145 | 141 | 286 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Arm I - Ginseng | Arm II - Placebo | Total |
|---|---|---|---|
| United States | 147 | 146 | 293 |
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Wake Forest University Health Sciences