Skip to content

  • About CRIS
  • Search
    • Basic Search
    • Advanced Search
    • Search by Topics
      • Condition(s)/Problem(s)
      • Intervention Type
      • Phase
    • Recently Registered
    • Recently Updated
  • FAQ
  • Statistics
  • Registration Data Set

Contact Us

criskorea@korea.kr
  • Status : Approved
    • First Submitted Date : 2013/11/11
    • Registered Date : 2013/11/12
    • Last Updated Date : 2013/11/11
Background Information
1.Background  
CRIS Registration Number KCT0000920 
Unique Protocol ID SM-IRB-10-0720-004  
Public/Brief Title Effects of Korean Red Ginseng for detoxification of bisphenol A, an endocrine disrupting chemical 
Scientific Title Protective effects of Korean Red Ginseng on Endocrine Disrupting Bisphenol A in Humans  
Acronym krg 
MFDS Regulated Study No
IND/IDE Protocol No
Registered at Other Registry No
Healthcare Benefit
Approval Status
 
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
Board Approval Status Submitted approval 
Board Approval Number SM-IRB-10-0720-004  
Approval Date 2010-08-03 
Institutional Review Board  
- Name Instritute Review Board of Sookmyung Women's University  
- Address  
- Telephone  
Data Monitoring Committee No  
Contact Details
3.Contact Details  
Contact Person for Principal Investigator / Scientific Queries
- Name Mihi Yang 
- Title Ph. D. 
- Telephone  
- Affiliation Sookmyung Women's Hospital 
- Address  
Contact Person for Public Queries
- Name Mihi Yang 
- Title Ph. D. 
- Telephone  
- Affiliation Sookmyung Women's Hospital 
- Address  
Contact Person for Updating Information
- Name Mihi Yang 
- Title Ph. D. 
- Telephone  
- Affiliation Sookmyung Women's Hospital 
- Address  
Status
4. Status Status  
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2010-09-01 , Actual
Target Number of Participant 22
Primary Completion Date 2010-12-31 , Actual
Study Completion Date 2011-03-10
Recruitment Status by Participating Study Site 1 
- Name of Study Site Sookmyung Women's Hospital 
- Recruitment Status Completed  
- Date of First Enrollment 2010-09-01 , Actual
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Korean Society of Ginseng  
- Organization Type Research Institute  
- Project ID 18  
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Sookmyung Women's Hospital 
- Organization Type University  
Study Summary
7. Study Summary  
Lay Summary Ethnopharmacological relevance: Korean red ginseng is a processed ginseng to enhance safety, preservation and efficacy. We studied safety and efficacy of KRG, focusing on female quality of life (QOL) and exposure to bisphenol A (BPA), an endocrine disrupting chemical, and investigated individual variations in susceptibility to KRG with the Sasang Typology, the personalized medicine used for hundred years in Korea.
Materials and Methods: We performed a single-blind randomized clinical trial. Study subjects were young women (N=22), consumed 2.7 g of KRG or placebo powder/day for 2 weeks and answered questionnaires including gynecologic complaints at the 4 time spots during the trial. We diagnosed the Sasang Typology with the questionnaire for the Sasang constitution Classification II (QSCCⅡ) and analyzed urinary total BPA and malondialdehyde (MDA), an oxidative stress biomarker.
Results: The KRG consumption decreased urinary BPA and MDA levels (ps<0.05) and alleviated ‘menstrual irregularity’, ‘menstrual pain’, and ‘constipation’ (ps<0.05). Soeumin (Lesser Yin person) showed KRG-related alleviation in insomnia, flushing, perspiration and appetite, rather than other Sasang types. During the KRG-intervention, no one experienced side effects of raw ginseng.
 
Study Design 정보
8. Study Design  
Study Type Interventional Study 
Study Purpose Treatment
Phase Phase1 
Intervention Model Parallel  
Blinding/Masking Single 
Blinded Subject Subject 
Allocation RCT 
Intervention Type Dietary Supplement  
Intervention Description take 9 capsules of placebo or KRG (2.7 g of KRG powder)/day after meals for 2 weeks  
Number of Arms
Arm 1 Arm Label placebo 
Target Number of Participant 11 
Arm Type Placebo comparator 
Arm Description take 9 capsules of placebo (238.13 mg of corn starch, 10 mg of powder flavor of KRG and 1.88 mg of coloring matters/capsule)/day after meals for 2 weeks 
Arm 2 Arm Label KRG group 
Target Number of Participant 11 
Arm Type Experimental 
Arm Description take 9 capsules of placebo or KRG (2.7 g of KRG powder)/day after meals for 2 weeks 
Subject Eligibility Information
9. Subject  
Condition(s)/Problem(s) * Endocrine, nutritional and metabolic disease
 
Rare Disease No
Inclusion
Criteria
Gender Female 
Age 20 Year ~ 25 Year
Description Volunteers, who experienced menstrual pain or irregularity were recruited , were on 7-11 days after the last menstruation and without bleeding.  
Exclusion Criteria people who had any medicine for diseases  
Healthy Volunteers Yes
Outcome Measure(s) Information
10. Outcome Measure(s)  
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
- Outcome questionnaires containing items of quality of life (QOL) including the 17 complaints 
- Timepoint before the trial and after the next menstruation 
Secondary Outcome(s) 1 
- Outcome urinary bisphenol a and maldondialdehyde 
- Timepoint day 0, 4, 8 and 14 days during the trial (4 spots) 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd Yes
Final Enrollment Number
Number of Publication
Publications 1 Mihi Yang, Min-Woo Hwang, Mirim Jin. Effects of Korean Red Ginseng (Panax Ginseng Meyer) on Bisphenol A Exposure and Gynecologic Complaints . BMC Complementary and Alternative Medicine. SCI. - ,   VOL :   page : ~
Results Upload  
Date of Posting Results 2013-11-12
Protocol URL or File Upload  
Brief Summary  
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement Not provided at time of Registration