A randomized double blind, placebo-controlled trial of efficacy and safety of Kamishoyosan in patients with climacteric symptoms

A randomized double blind, placebo-controlled trial of efficacy and safety of Kamishoyosan in patients with climacteric symptoms - A randomized double blind, placebo-controlled trial of efficacy and safety of Kamishoyosan in patients with climacteric symptoms

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005079

Enrollment

200

Registered

2011-03-01

Start date

2011-04-01

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

Climacteric symptoms

Interventions

Kamishoyosan 7.5 g/day in three divided doses before or between meals. Treatment duration: 56 days Placebo (A pharmacologically inactive substance made of lactose which looks, tastes and smells i

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Patients who are diagnosed with climacteric symptom (not mentioned about menopause) 2) Patients who give written informed consent 3) Patients with SDS raw scores less than 60 points. 4) Patients who have not been treated with hormone replacement therapy, Kampo medicine therapy and/or prohibited concomitant drugs (sex steroid hormone, antianxiety drugs, antidepressant drug, SSRI, SNRI, autonomic drugs, Kallidinogenase, hypnotic drug) within 4 weeks before enrollment

Exclusion criteria

Exclusion criteria: 1) Patients with serious gastrointestinal weakness 2) Patients with anorexia, nausea and/or vomiting 3) Patients with psycho-neurologic disease (SDS>=60) 4) Patients with a history of drug allergy or hypersensitivity reaction to Kampo medicine 5) Patients with serious complications (hepatic, renal, cardiac diseases or malignancy tumor) 6) Patients who have been participated in other clinical trial within 4months before enrollment, or will participate in a clinical trial. 7) Patients who are assessed to be inappropriate for study participation by the investigator.

Design outcomes

Primary

Measure	Time frame
Drug efficacy Evaluation of chronological changes with questionnaires Self-rating depression Scale, SDS Severity and frequency of hot flash State-Trait Anxiety Inventory, STAI SF-36 *Questionnaire for assessment of climacteric symptoms in Japanese women	—

Secondary

Measure	Time frame
Drug Safety Adverse events, Side effects Biochemical examination Hormonal examination (serum FSH, TSH) Weight, Blood pressure	—

Countries

Japan

Contacts

Public ContactKunihiko Hayashi

Gunma University School of Health Science

khayashi@health.gunma-u.ac.jp027-220-8974

Outcome results

None listed

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