Single center, double-blind, randomized, parallel trial to evaluate the efficacy of rhizopus koji extract containing food in subjects with menopause symptom

Single center, double-blind, randomized, parallel trial to evaluate the efficacy of rhizopus koji extract containing food in subjects with menopause symptom - Evaluation study of the efficacy for menopause symptom

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017821

Enrollment

Registered

2015-06-24

Start date

2015-06-26

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

menopause symptom

Interventions

rhizopus koji extract containing food Placebo

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: (1)Japanese female ages 45-59 years old (inclusive) (2)Subjects with Kupffer man menopausal index more than 23 scores (3)Willing and able to provide signed written informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Kupffer man menopausal index ( Abe modification)	—

Secondary

Measure	Time frame
SDS,STAI	—

Countries

Japan

Contacts

Public ContactShigeru Imai

CROee Inc. Evidence Division

imai@croee.com03-5953-2108

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026