An open-label, randomized clinical study to evaluate efficacy and safety of Kamishoyosan for Premenstrual syndrome

Taniguchi Fuminori0 个研究点目标入组 50 人开始时间: 2022年4月11日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•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

•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

发起方

Taniguchi Fuminori