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Efficacy of an Extract of Concentrated Korean Red Ginseng for Preventing Upper Respiratory Tract Infections

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier:
NCT01478009
First received: November 16, 2011
Last updated: November 26, 2012
Last verified: November 2012
History of Changes
Results First Received: July 2, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Condition: Healthy Subjects
Interventions: Dietary Supplement: Korean red 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
Participants were recruited through local advertising and doctor referrals from hospital outpatients and general practice clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The criteria were an age from 30 to 70 years, have contracted at least 2 colds in the past year. Subjects were excluded if they had been vaccinated against influenza in the previous 6 months.

Reporting Groups
  Description
KRG(Korean Red Ginseng) Extract

KRG Extract(3times/day, 9capsules/day, 3g/day) for 12weeks

KRG Extract : KRG Extract was extracted at high temperatures (above 95℃)
Placebo

Placebo(3times/day, 9capsules/day, 3g/day) for 12weeks

Placebo : Amount and calorie of placebo are same with KRG Extract.

Participant Flow:   Overall Study
    KRG(Korean Red Ginseng) Extract     Placebo  
STARTED     50     50  
COMPLETED     49     49  
NOT COMPLETED     1     1  



  Baseline Characteristics
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Reporting Groups
  Description
KRG Extract No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    KRG Extract     Placebo     Total  
Number of Participants  
[units: participants]
 		  50     50     100  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     50     50     100  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  45.5  ± 8.1     46.3  ± 9.8     45.9  ± 8.9  
Gender  
[units: participants]
 		     
Female     28     34     62  
Male     22     16     38  
Region of Enrollment  
[units: participants]
 		     
Korea, Republic of     50     50     100  



  Outcome Measures
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1.  Primary:   Frequency of ILI(Influenza Like Illness)   [ Time Frame: 12 weeks ]
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2.  Secondary:   Symptom Severity of All Colds   [ Time Frame: 12 weeks ]
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3.  Secondary:   Total Number of Days of Symptoms and Duration of All Colds   [ Time Frame: up to 12 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Chang-Seop Lee
Organization: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
phone: 82-63-276-8284
e-mail: lcsmd@jbnu.ac.kr


No publications provided by Chonbuk National University Hospital

Publications automatically indexed to this study:


Responsible Party: Soo-Wan Chae, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01478009     History of Changes
Other Study ID Numbers: IJRG-INFL-KRG
Study First Received: November 16, 2011
Results First Received: July 2, 2012
Last Updated: November 26, 2012
Health Authority: South Korea: Institutional Review Board