Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT00752895
Status:
COMPLETED
Last Update Posted:
2021-09-28
First Post:
2008-09-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
American Ginseng Extract in Preventing Respiratory Infection and in Reducing Antibiotic Use in Patients With CLL
Sponsor:
Wake Forest University Health Sciences
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo Controlled Trial of North American Ginseng Extract (CVT-E002; COLD-fX®) to Prevent Respiratory Infection and Reduce Antibiotic Use in Patients With Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
OBJECTIVES:
Primary
* To assess the effect of American ginseng extract on the number of days of acute respiratory infection (ARI) during the peak respiratory illness season (January-March) in patients with chronic lymphocytic leukemia (CLL).
* To determine the safety of American ginseng extract in these patients evaluated according to NCI CTCAE v3.0.
Secondary
* To assess the effect of this treatment on antibiotic use days (AUDs).
* To assess the effect of this treatment on the rate of all infections diagnosed by a physician.
* To assess the effect of this treatment on the duration and severity of each ARI episode.
* To assess the effect of this treatment on major infections defined as infection severe enough to require hospitalization or intravenous antibiotics.
* To assess the effect of this treatment on the incidence of herpes zoster infection defined as an episode of physician-diagnosed zoster infection.
* To assess the effect of this treatment on CLL disease activity (i.e., serum IgG, total lymphocyte count, platelet count, and Rai staging).
* To determine the incidence of ARI and type of illness in an untreated cohort of CLL patients over an entire winter respiratory illness season (January 1- April 30).
Tertiary
* To determine the effect of this treatment on the incidence of influenza and respiratory syncytial virus confirmed by a physician.
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.
* Arm I: Patients receive oral American ginseng extract twice daily.
* Arm II: Patients receive oral placebo twice daily. Treatment in both arms continues for up to 4 months in the absence of illness or adverse events.
After completion of study treatment, patients are followed at 4 weeks by phone.
Primary
* To assess the effect of American ginseng extract on the number of days of acute respiratory infection (ARI) during the peak respiratory illness season (January-March) in patients with chronic lymphocytic leukemia (CLL).
* To determine the safety of American ginseng extract in these patients evaluated according to NCI CTCAE v3.0.
Secondary
* To assess the effect of this treatment on antibiotic use days (AUDs).
* To assess the effect of this treatment on the rate of all infections diagnosed by a physician.
* To assess the effect of this treatment on the duration and severity of each ARI episode.
* To assess the effect of this treatment on major infections defined as infection severe enough to require hospitalization or intravenous antibiotics.
* To assess the effect of this treatment on the incidence of herpes zoster infection defined as an episode of physician-diagnosed zoster infection.
* To assess the effect of this treatment on CLL disease activity (i.e., serum IgG, total lymphocyte count, platelet count, and Rai staging).
* To determine the incidence of ARI and type of illness in an untreated cohort of CLL patients over an entire winter respiratory illness season (January 1- April 30).
Tertiary
* To determine the effect of this treatment on the incidence of influenza and respiratory syncytial virus confirmed by a physician.
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.
* Arm I: Patients receive oral American ginseng extract twice daily.
* Arm II: Patients receive oral placebo twice daily. Treatment in both arms continues for up to 4 months in the absence of illness or adverse events.
After completion of study treatment, patients are followed at 4 weeks by phone.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U10CA081851 | NIH | None | https://reporter.nih.gov/quic… | View |
| REBACCCWFU98308 | OTHER | NCI | View |