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

Not Applicable

Completed

• Conditions: Diseases of The genitoruinary system

• Registration Number: KCT0006019
• Lead Sponsor: Pulmuone

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2016-03-25
• Last Update Posted: 22 April 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Changes of Modified KMI scores

Secondary Outcome Measures

Name	Time	Method
Changes of Modified KMI subcategories score, ALP, OC, and urine-NTx