Clinical trial for the evaluation of the efficacy and safety of isoflavone on menopausal symptoms.

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0006019

Enrollment

Registered

2021-03-24

Start date

2014-07-16

Completion date

Unknown

Last updated

2021-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : 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.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Postmenopausal women aged between 40 and 60 years. 2) Modified kupperman index > 20

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
Changes of Modified KMI subcategories score, ALP, OC, and urine-NTx	—

Primary

Measure	Time frame
Changes of Modified KMI scores	—

Countries

Korea, Republic of

Contacts

Public ContactHye In Kim

Yonsei University Health System, Severance Hospital

hyein24@yuhs.ac+82-2-2228-2236

Outcome results