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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01478009
Recruitment Status : Completed
First Posted : November 23, 2011
Results First Posted : December 25, 2012
Last Update Posted : December 25, 2012
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Condition: Healthy Subjects
Interventions: Dietary Supplement: Korean red ginseng
Dietary Supplement: Placebo

  Participant Flow

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
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(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 

  Baseline Characteristics

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.
No text entered.

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

Baseline Measures
   KRG Extract   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   50   100 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   50   50   100 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 45.5  (8.1)   46.3  (9.8)   45.9  (8.9) 
[Units: Participants]
Female   28   34   62 
Male   22   16   38 
Region of Enrollment 
[Units: Participants]
Korea, Republic of   50   50   100 

  Outcome Measures

1.  Primary:   Frequency of ILI(Influenza Like Illness)   [ Time Frame: 12 weeks ]

2.  Secondary:   Symptom Severity of All Colds   [ Time Frame: 12 weeks ]

3.  Secondary:   Total Number of Days of Symptoms and Duration of All Colds   [ Time Frame: up to 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  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.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

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

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Soo-Wan Chae, Chonbuk National University Hospital Identifier: NCT01478009     History of Changes
Other Study ID Numbers: IJRG-INFL-KRG
First Submitted: November 16, 2011
First Posted: November 23, 2011
Results First Submitted: July 2, 2012
Results First Posted: December 25, 2012
Last Update Posted: December 25, 2012