Pilot study into Unkeito for irregular menstruation

Recruiting

• Conditions: Irregular menstruation

• Registration Number: jRCTs031240402

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-11
• Study Start: 2025-01-17
• Last Update Posted: 2025-02-19

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

1. Patients with an average of the most recent two menstrual cycles were more than 39 days but less than 90 days.
2. Women aged 18 to under 35 at the time of consent.
3. Patients who can confirm the start date of menstruation for the past 3 or more by an app or other means.
4. Patients who can take study drugs orally
5. Patients who have received a thorough explanation of the study and who have given written consent of their own free will based on a thorough understanding of the study.
6. Patients who are able to make outpatient visits in accordance with the research implementation schedule.

Exclusion Criteria

1. Patients with primary amenorrhea
2. Patients with premature ovarian failure
3. Patients undergoing treatment for thyroid dysfunction
4. Patients with severe obesity or emaciation (BMI less than 15 or more than 40)
5. Patients who have been treated with oral contraceptives or sex hormones within 90 days before obtaining consent
6. Patients who have been treated with psychotropic drugs within 4 weeks before obtaining consent
7. Patients with ovarian or uterine lesions that require immediate examination or treatment
8. Patients with serious mental diseases
9. Patients with serious coexisting diseases (liver disease, renal disease, cardiac disease, blood disease, metabolic disease, malignant tumor, etc.)
10. Patients who are pregnant or may be pregnant and wish to become pregnant during the study
11. Patients who are lactating women
12. Patients with allergies to Kampo medicines
13. Patients who participated in a clinical trial or other clinical studies within 12 weeks prior to obtaining consent
14. Patients treated with Kampo medicines for menstrual irregularity within 4 weeks prior to obtaining consent: Bojiogito, Tokishakuyakusan, Kamishoyosan, Keishibukuryogan, Daiobotanpito, Unseiin, Tokakujokito, Nyoshinsan, Shimotsuto, Tsudosan, Unkeito, Keishibukuryogankayokuinin.
15. Other patients who are judged inappropriate for participation in this study by the investigator or co-investigator.

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
The change in menstrual cycle length from the baseline menstrual cycle	24 weeks of administration	The difference in the number of days between the baseline menstrual cycle length (average length of the three most recent cycles at the start of administration, Week 0) and the most recent menstrual cycle length at 24 weeks of administration.

Secondary Outcome Measures

Name	Time	Method
Proportion of transition to normal menstrual cycle		Proportion of transition to normal menstrual cycle (25-38 days)
The change in menstrual cycle length and rate of change over time		The change in menstrual cycle length and rate of change over time
Ovulation evaluation		Ovulation evaluation (basal body temperature)
Menstrual Distress evaluation		Menstrual Distress evaluation (MDQ)
Depression evaluation		Depression evaluation (CES-D)
Rate of change in menstrual cycle length		Rate of change in menstrual cycle length
The most recent menstrual cycle length at 24 weeks of administration	24 weeks	The most recent menstrual cycle length at 24 weeks of administration
Sleep evaluation		Sleep evaluation (AIS)
Chill evaluation		Chill evaluation (NRS)
Evaluation of skin symptoms		Evaluation of skin symptoms (NRS)