Randomized, Double-blinded, Placebo-controlled Study of Rubus coreanus Miquel and Astragalus membranaceus Bunge extract mixture to Evaluate Efficacy and Safety on Healthy Subjects with Postmenopausal Syndrome

Not Applicable

Active, not recruiting

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0005546
• Lead Sponsor: KolmarBNH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 November 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1. Women aged 20-40 years
2. Women in menopausal period (amenorrhea 12 months in a row) OR menopaupausal transition period (amenorrhea 3 months in a row AND FSH > 40 IU/L)
3. Women with menopausal symptoms moderate or above degree (Kupperman Index = 20)
4. Women signed the informed consent form

Exclusion Criteria

1. Clinically significant abnormality in mammography (breast imaging-reporting and data system category (BI-RADS) 0 OR above 3. Nevertheless, BI-RADS 0 can be enrolled by the researchers’ decision)
2. Endometrial thickness above 5 mm by vaginal ultrasonography
3. History of surgery- or chemotherapy induced amenorrhea, undiagnosed vaginal hemorrhage
4. History of hormone therapy in 6 months before the first visit
5. History of continuous taking health functional food or herbal medicine affecting menopausal health, blood lipids (neutral fat, cholesterol, etc.), blood pressure or blood flow in 1 month before the first visit
6. Medicine taking history of sleep inducer, antidepressant, selective estrogen receptor modulator, lipid-lowering drugs, antihypertensive drugs
7. History of endometrial hyperplasia, uterine endometrial cancer, sex steroid dependet organ tumors
8. History of severe migraine headache, thromboembolic disorders, cerebrovascular disorders, serious cardiovascular condition within 1 year before the first visit
9. Uncontrolled underlying disease including liver or renal function failure (ALT or AST above 3 fold higher than reference level, creatinine > 2.0 mg/dL), hypertension (SBP > 160 mmHg or DBP > 100 mmHg), thyroid disease, diabetes, hyperlipidemia
10. Addicted drugs or alcohol
11. Habitual taking of large amount of isoflavone
12. Continuous intensive exercise within 3 months before the first visit (=10 hours/week)
13. Hypersensitivity to the test material or ingredients in the test material
14. Participated in other clinical research within 1 month before the first visit
15. Inappropriate for the test by the researchers’ decision

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Kupperman Index

Secondary Outcome Measures

Name	Time	Method
menopause rating scale, MRS;lipid profile (total cholesterol, triglyceride, LDL-C, HDL-C);laboratory test, vital signs;follicle stimulating hormone, FSH;endometrial thickness;Estradiol, E2;luteinizing hormone