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

JRCT ID: jRCTs061220001

Registered date:11/04/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Premenstrual syndrome
• Date of first enrollment: 13/05/2022
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Kamishoyosan administration

Outcome(s)

• Primary Outcome: Pre-menstrual MDQ Total score change from baseline to final evaluation

Secondary Outcome

1) Change over time of MDQ (Pre-menstrual total score, mid-menstrual total score, post-menstrual total score, each subscale score)
2) Sleep evaluation
3) Evaluation specific to Kampo Medicine
4) Menstruation-related symptom evaluation
5) Work Productivity and Activity Impairment Questionnaire
6) Cold, stiff shoulder score
7) Overall impression after participating in the research
8) Sleep/heart rate evaluation using a smart watch
9) Adversed experience

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 45age old
• Gender: Female

Include 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

Exclude 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

Related Information

• Primary Sponsor: Taniguchi Fuminori
• Source(s) of Monetary Support: TSUMURA &amp; CO.