Status Approved
First Submitted Date
2021/03/15
Registered Date
2021/03/24
Last Updated Date
2021/03/15
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0006019 |
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Unique Protocol ID | 4-2014-0399 |
Public/Brief Title | Clinical trial for the evaluation of the efficacy and safety of isoflavone on menopausal symptoms. |
Scientific Title | A 12 week, multi-center, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Soybean extract complex on menopausal symptoms. |
Acronym | |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | 4-2014-0399 |
Approval Date | 2014-07-09 |
Institutional Review Board Name | Yonsei University Health System, Severance Hospital, Institutional Review Board |
Institutional Review Board Address | 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea |
Institutional Review Board Telephone | 02-2228-0500 |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Seok Kyo Seo |
Title | professor |
Telephone | +82-2-2228-2236 |
Affiliation | Yonsei University Health System, Severance Hospital |
Address | 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea |
Contact Person for Public Queries | |
Name | Hye In Kim |
Title | fellow |
Telephone | +82-2-2228-2236 |
Affiliation | Yonsei University Health System, Severance Hospital |
Address | 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea |
Contact Person for Updating Information | |
Name | Seok Kyo Seo |
Title | professor |
Telephone | +82-2-2228-2236 |
Affiliation | Yonsei University Health System, Severance Hospital |
Address | 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea |
4. Status
Study Site | Multi-center Number of center : 2 | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2014-07-16 Actual | |
Target Number of Participant | 80 | |
Primary Completion Date | 2015-10-05 , Actual | |
Study Completion Date | 2016-03-25 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Yonsei University Health System, Severance Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2014-07-22 , | |
Recruitment Status by Participating Study Site 2 | ||
Name of Study | National Health Insurance Service Ilsan Hospital | |
Recruitment Status | Completed | |
Date of First Enrollment | 2014-07-16 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Pulmuone |
Organization Type | Others |
Project ID | PMO_CPX |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Pulmuone |
Organization Type | Others |
7. Study Summary
Lay Summary | This study was conducted as a double-blind, randomized, placebo-controlled clinical trial. The aim of this study was to evaluate the efficacy and safety of Soybean extract complex on menopausal symptoms in postmenopausal women. Forty participants were randomly assigned to the placebo group, and another 40 were placed in the Soybean extract complex group. |
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8. Study Design
Study Type | Interventional Study |
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Study Purpose | Supportive Care |
Phase | Not applicable |
Intervention Model | Parallel |
Blinding/Masking | Double |
Blinded Subject | Subject, Investigator |
Allocation | RCT |
Intervention Type | Dietary Supplement |
Intervention Description | The soybean extract complex group took one tablet two times a day (Soybean extract complex 190mg/day) for 12 weeks. The placebo group was provided with identically shaped tablet. The placebo was also taken two times a day for 12 weeks. |
Number of Arms | 2 |
Arm 1 |
Arm Label The soybean extract complex group |
Target Number of Participant 40 |
|
Arm Type Active comparator |
|
Arm Description The soybean extract complex group took one tablet two times a day (Soybean extract complex 190mg/day) for 12 weeks. |
|
Arm 2 |
Arm Label The placebo group |
Target Number of Participant 40 |
|
Arm Type Placebo comparator |
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Arm Description The placebo group took one identically shaped placebo tablet two times a day for 12 weeks. |
9. Subject Eligibility
Condition(s)/Problem(s) |
* (N00-N99)Diseases of the genitourinary system (N95.1)Menopausal and female climacteric states postmenopause |
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Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age 40Year~60Year |
|
Description 1) Postmenopausal women aged between 40 and 60 years. 2) Modified kupperman index > 20 |
|
Exclusion Criteria |
1) BMI (Body Mass Index)> 30 Kg/m2 2) Women used hormone therapy for the past 3 months 3) Women with endometrial hyperplasia, cevical cencer, endometrial cacer, breast cancer, or estrogen dependent tumor 4) Women with severe migrane, thromboembolism, cerebrovascular disease, or cardiovascular disease for the past one year 5) Women with psychical disorder 6) Women with undiagnosed vaginal bleeding 7) Women with uncontrolled hypertension(> 160/100mmHg) 8) Women with uncontrolled DM (fasting glucose > 180mg/dL or started new DM drug within 3 months) 9) Women with uncontrolled thyroid disease 10) Women with drug or alcohol abuse 11) More than three times over the normal limit of ALT or AST 12) More than two times over the normal limit of creatinine 13) Women with abnormal mammography/PAP smear (BI-RADS Category > 3, PAP smear > ASCUS) 14) Women with partitipating other clinical trial 15) if reserchers are deemed inappropriate in this clinical trial 16) Women used thyroid hormone, Clonidine, anticoagulant agent(Warfarin, Aspirin, Clipidogrel)within 3 months 17) Women used complementary and alternative medicine for the past 1 months |
Healthy Volunteers | Yes |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Changes of Modified KMI scores |
|
Timepoint | After 6 weeks and 12 weeks |
|
Secondary Outcome(s) 1 | ||
Outcome | Changes of Modified KMI subcategories score, ALP, OC, and urine-NTx |
|
Timepoint | After 6 weeks and 12 weeks |
11. Study Results and Publication
Result Registered |
Yes
Results Upload |
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Final Enrollment Number | 80 |
Number of Publication | 0 |
Results Upload | 결과보고서요약.pdf |
Date of Posting Results | 2021/03/24 |
Protocol URL or File Upload | 프로토콜.pdf |
Brief Summary | In this study, through the Modified KMI questionnaire, it was confirmed that very significant menopausal symptoms and even some vasomotor symptoms were improved. In particular, in this study, there were significant differences between groups ingested at 12 weeks in the symptoms of numbness, fatigue symptoms, muscle joint pain, chest palpitations, vaginal dryness and decreased secretion. However, it had no effect on emotions, sleep, pain, and cognitive impairment. In other studies, both soybean and hop extracts were reported to be very effective in relation to hot flushing. In this study, the test group showed a higher decrease, but there was no significant difference between the intake groups. This can be attributed to the fact that the characteristic imagination of the study, especially in a short period of time, is very sensitive to the placebo effect, which can have a great influence on the overall result, and that symptoms can naturally decrease with time. In the test group, the decrease in ALP, an indicator of bone loss, and Urine-NTX, a by-product produced during bone decomposition, could improve bone health as in previous studies, but there was no significant difference between the intake groups. This is thought to be helpful in evaluating more subjects and long-term intake. |
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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