Single center, double-blind, randomized, parallel trial to evaluate the efficacy of rhizopus koji extract containing food in subjects with menopause symptom
Not Applicable
- Conditions
- menopause symptom
- Registration Number
- JPRN-UMIN000017821
- Lead Sponsor
- SHIKOSHI RESEARCH INSTITUTE FOR PHYSIOLOGY CO.,LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
(1)Subjects with severe hepatic, renal, cardiac, gastrointestinal, hematologic, endocrine and metabolic diseases / disorders (2)Subjects with history of sensitivity to the ingredients (3)Subjects who had participated in other clinical trials including drug and food within 1 month. (4)Pregnant, lactating women or willing to be pregnancy during the study (5)Any candidate considered to be unsuitable for enrollment in the opinion of the principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Kupffer man menopausal index ( Abe modification)
- Secondary Outcome Measures
Name Time Method SDS,STAI