臨床研究等提出・公開システム

An open-label, single-arm, pilot study of Unkeito for irregular menstruation

Pilot study into Unkeito for irregular menstruation

Harada Miyuki

The University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku, Tokyo

haradamtky@gmail.com

Harada Miyuki

The University of Tokyo Hospital

7-3-1 Hongo, Bunkyo-ku, Tokyo

+81-3-3815-5411

haradamtky@gmail.com

Recruiting

Oct. 11, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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.

Female

Irregular menstruation

Unkeito 7.5g divided into 2 to 3 doses and administered orally before or between meals per day.

Irregular menstruation / oligomenorrhea

Unkeito/Kampo medicine/ Japanese traditional medicine

The change in menstrual cycle length from the baseline menstrual cycle, defined as the average length of the three most recent cycles at the start of administration (Week 0), to the menstrual cycle after 24 weeks of administration.
This is calculated as the difference in the number of days between the baseline menstrual cycle length and the most recent menstrual cycle length at 24 weeks of administration.

1.Proportion of transition to normal menstrual cycle(25-38 days)
2.Rate of change in menstrual cycle length
3.The most recent menstrual cycle length at 24 weeks of administration
4.The change in menstrual cycle length and rate of change over time
5.Ovulation evaluation(basal body temperature)
6.Menstrual Distress evaluation(MDQ)
7.Depression evaluation(CES-D)
8.Sleep evaluation(AIS)
9.Chill evaluation(NRS)
10.Evaluation of skin symptoms(NRS)

+81-3-5841-3600

Sept. 24, 2024

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