Status Approved
First Submitted Date
2013/11/11
Registered Date
2013/11/12
Last Updated Date
2013/11/14
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0000920 |
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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 |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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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 |
Institutional Review Board Address | |
Institutional Review Board Telephone | |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Mihi Yang |
Title | Ph. D. |
Telephone | +82-2-2077-7179 |
Affiliation | Sookmyung Women's Hospital |
Address | |
Contact Person for Public Queries | |
Name | Mihi Yang |
Title | Ph. D. |
Telephone | +82-2-2077-7179 |
Affiliation | Sookmyung Women's Hospital |
Address | |
Contact Person for Updating Information | |
Name | Mihi Yang |
Title | Ph. D. |
Telephone | +82-2-2077-7179 |
Affiliation | Sookmyung Women's Hospital |
Address |
4. Status
Study Site | Single | |
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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 | Sookmyung Women's Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2010-09-01 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Korean Society of Ginseng |
Organization Type | Research Institute |
Project ID | 18 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Sookmyung Women's Hospital |
Organization Type | University |
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. |
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8. Study Design
Study Type | Interventional Study |
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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 | 2 |
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 |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (N00-N99)Diseases of the genitourinary system (N94.6)Dysmenorrhoea, unspecified |
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Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age 20Year~25Year |
|
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 |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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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) |
11. Study Results and Publication
Result Registered | Yes |
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Final Enrollment Number | |
Number of Publication | 1 |
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 |
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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