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.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Pulmuone
- Enrollment
- 80
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified