Endometriosis
Conditions
Interventions
TSUMURA Tokishakuyakusan Extract Granules for Ethical Use Oral administration 7.5g/day in 2 or 3 divided doses before or between meals.
Sponsors
Tottori University Faculty of Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Patients who had diagnosed with endometriosis(including adenomyosis uteri) 2)Premenopausal women whose age of twenty and above 3)Patients who scored 4 or 5 in five-grade Likert scale which express average satisfaction in dysmenorrhea treatment for the last 3 cycles before acquiring consent 4)Patients who are taking LEP continuously for 3 cycles before acquiring consent 5) Patients determined to require and controllable taking LEP throughout the study period 6)Outpatients 7) Patients whose consent document was obtained in this study
Exclusion criteria
Exclusion criteria: 1)Patients who have an abnormal genital hemorrhage which is not diagnosed or an endometrial polyp or an endometrial hyperplasia 2)Patients who have an extreme uterine swelling 3)Patients who need treatments other than LEP or patients who need surgery for endometriosis(including adenomyosis uteri) 4)Patients with serious complications (liver, kidney, heart, blood, or metabolic disorders) 5)Pregnant patients or patients who are probably pregnant 6)Breast-feeding patients 7)Patients who have allergy to Kampo medicine 8)Patients who have participated in other clinical trial or clinical research in the last three months at the point of acquiring consent 9)Patients who had treatments of hormonal drugs other than LEP (middle dose estrogen progesterone, GnRHagonist, LNG-IUS or Dienogest) in the last three months at the point of acquiring consent 10)Patients who had Kampo medicine treatment in the last four weeks at the point of acquiring consent 11)Patients who has changed the dosage and administration of limited concomitant drugs 12)Patients considered inappropriate by the study investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endometriosis QOL questionnaire EHP-30 (Endometriosis Health Profile-30) | — |
Countries
Japan
Contacts
Public ContactFuminori Taniguchi
Tottori University Faculty of Medicine Division of Reproductive-Perinatal Medicine and Gynecologic Oncology, Department of Surgery
Outcome results
None listed