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Clinical Trials/KCT0006019
KCT0006019
Completed
未知

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.

Pulmuone0 sites80 target enrollmentTBD

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.

Registry
who.int
Start Date
TBD
End Date
March 25, 2016
Last Updated
5 years ago
Study Type
Interventional Study
Sex
Female

Investigators

Sponsor
Pulmuone

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

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