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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 University Health Sciences
ClinicalTrials.gov Identifier:
NCT00752895
First received: September 13, 2008
Last updated: December 20, 2016
Last verified: November 2016
Results First Received: September 28, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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 
Overall Participants Analyzed 
[Units: Participants]
 147   146   293 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Median (Full Range)
 65 
 (43 to 87) 
 66 
 (44 to 82) 
 65 
 (43 to 87) 
Gender 
[Units: Participants]
Count of Participants
     
Female      65  44.2%      60  41.1%      125  42.7% 
Male      82  55.8%      86  58.9%      168  57.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   147   146   293 


  Outcome Measures
  Show All Outcome Measures

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 University Health Sciences
ClinicalTrials.gov Identifier: NCT00752895     History of Changes
Other Study ID Numbers: REBACCCWFU98308
U10CA081851 ( US NIH Grant/Contract Award Number )
Study First Received: September 13, 2008
Results First Received: September 28, 2015
Last Updated: December 20, 2016