Clinical study to evaluate efficacy and safety of Kamishoyosan for Premens trual syndrome

Phase 4

Recruiting

• Conditions: Premenstrual syndrome

• Registration Number: JPRN-jRCTs061220001
• Lead Sponsor: Taniguchi Fuminori

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-04-11
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1) Patients diagnosed with PMS based on ACOG PMS diagnostic criteria
2) Patients who meet a toral score of 30 or higher on premenstrual MDQ at pretreatment period
3) Patients aged 18 to 45 at the time of consent
4) Patients with regular menstrual cycle of 25 to 38 days
5) Patients who can take study drugs orally
6) Outpatient

Exclusion Criteria

1) Patients who have been treated with oral contraceptives or sex hormones within 4 weeks before obtaining consent
2) Patients who have been treated with antidepressants within 4 weeks before obtaining consent
3) Patients who have been treated with anxiolytics within 4 weeks before obtaining consent
4) Patients who have been treated with sleeping pills within 4 weeks before obtaining consent
5) Patients who have been treated with diuretics within 4 weeks before obtaining consent
6) Patients who have been treated with effective drug against PMS within 4 weeks before obtaining consent
7) Patients with serious mental disease
8) Patients with serious disease
9) Patients who are pregnant or may be pregnant and wish to become pregnant
10) Patients who are lactating women
11) Patients with allergies to Kampo medicines
12) Patients who participated in clinical trials or other clinical studies within 3 months before obtaining consent
13) Patients treated with study drug within 4 weeks prior to consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified