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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest NCORP Research Base
ClinicalTrials.gov Identifier:
NCT00752895
First received: September 13, 2008
Last updated: September 28, 2015
Last verified: September 2015
Results First Received: September 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Leukemia
Interventions: Dietary Supplement: American ginseng
Dietary Supplement: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Arm I - Ginseng

Patients receive oral American ginseng extract twice daily.

American ginseng: Given orally

Arm II - Placebo

Patients receive oral placebo twice daily.

Placebo: Given orally


Participant Flow:   Overall Study
    Arm I - Ginseng     Arm II - Placebo  
STARTED     147     146  
COMPLETED     139     143  
NOT COMPLETED     8     3  
Withdrawal by Subject                 8                 3  



  Baseline Characteristics
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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.
All randomized participants

Reporting Groups
  Description
Arm I - Ginseng

Patients receive oral American ginseng extract twice daily.

American ginseng: Given orally

Arm II - Placebo

Patients receive oral placebo twice daily.

Placebo: Given orally

Total Total of all reporting groups

Baseline Measures
    Arm I - Ginseng     Arm II - Placebo     Total  
Number of Participants  
[units: participants]
  147     146     293  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     71     64     135  
>=65 years     76     82     158  
Age  
[units: years]
Median (Full Range)
  65  
  (43 to 87)  
  66  
  (44 to 82)  
  65  
  (43 to 87)  
Gender  
[units: participants]
     
Female     65     60     125  
Male     82     86     168  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     2     2  
Not Hispanic or Latino     147     144     291  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
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  
[units: participants]
     
United States     147     146     293  



  Outcome Measures
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1.  Primary:   Acute Respiratory Infection (ARI) Days   [ Time Frame: 3 months ]

2.  Secondary:   Number of Antibiotic Use Days   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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
e-mail: dcase@wakehealth.edu



Responsible Party: Wake Forest NCORP Research Base
ClinicalTrials.gov Identifier: NCT00752895     History of Changes
Other Study ID Numbers: CCCWFU98308
U10CA081851 ( US NIH Grant/Contract Award Number )
Study First Received: September 13, 2008
Results First Received: September 28, 2015
Last Updated: September 28, 2015
Health Authority: United States: Federal Government