Efficacy and Safety of Germinated & fermented Soybean extract on menopausal symptoms; A 12week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Not Applicable

Recruiting

• Conditions: Endocrine, nutritional and metabolic disease

• Registration Number: KCT0002961
• Lead Sponsor: HUBIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1) Women 40 to 65 years of age who are in the menopausal transition (when there is no menstruation for 3 months or more and FSH(Follicle stimulating hormone) 30 mIU/mL or more) or menopause (1 year or more after the last menstrual period)
2) Women with a KMI (kupperman index) score of 25 or higher
3) Women who have agreed to participate in this trial before the start of the clinical trial and who have written an informed consent form

Exclusion Criteria

1) Women with a body mass index (BMI) greater than 30 kg / m2
2) Women using hormone preparations such as female hormones or similar hormone preparations (plant extracts, etc.) within 3 months
3) Women with a history of endometrial hyperplasia, uterine cancer, endometrial cancer, breast or breast disease, sex hormone related cancer
4) Women who have undergone hysterectomy
5) A woman with a history of severe migraine within the past 1 year, diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or coronary angioplasty
6) Women with severe mental illnesses such as depression and anxiety disorder, or those currently taking psychotropic drugs such as antidepressants
7) Women with irregular uterine bleeding after 1 year of menopause
8) Patients with uncontrolled hypertension(160/100mmHg or higher, after 10 minutes of clinical test subjects)
9) Patients with diabetes whose blood sugar is not controlled (fasting glucose 180 mg / dL or diabetes mellitus within 3 months)
10) Thyroid patients with TSH less than or equal to 0.1 µU / ml or 10 µU/ml or more
11) drug or alcohol abuser
12) If ALT(Alanine transaminase) or AST(Aspartate transaminase ) exceeds 3 times the normal upper limit of the research institute
13) If creatinine exceeds twice the upper limit of the normal level of research institute
14) If there is a clinically significant abnormality in Mammography / PAP smear[BIRADS(the Breast Imaging Reporting and Data System) Category 0 or 3 or more, PAP smear is not abnormal up to ASCUS(Atypical Cells of Undetermined Significance)]
(However, if BI-RADS(the Breast Imaging Reporting and Data System) Category is 0, it can be registered under the judgment of PI and also BI-RADS(the Breast Imaging Reporting and Data System) Category 3 can be registered if the additional test shows that the test is positive)
15) If you have participated in another clinical trial within one month of the start of this trial or plan to participate in another clinical trial during the trial period
16) If PI judges that the test is inappropriate for this clinical trial
17) Women using thyroid hormone preparations, clonidine, anticoagulants or antithrombotic agents (Aspirin, Warfarin, Clopidogrel, etc.) within 3 months
18) Women who took medicines or health functional foods related to women's menopause within a month
19) Those taking or administering a therapeutic agent for osteoporosis, such as a bisphosphonate preparation

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Kupperman Index(11 items) total score change

Secondary Outcome Measures

Name	Time	Method
Modified Kupperman index(11 items, Dryness of vagina) each score change;MRS(Menopause Rating Scale);ALP(Alkaline phosphatase), OC(Osteocalcin);Urine N-telopeptide(NTx);CRP(C-reactive protein)