The evaluation of the efficacy and the safety of TSUMURA Tokishakuyakusan Extract Granules for Ethical Use on endometriosis patients with dysmenorrhea
- Conditions
- Endometriosis
- Registration Number
- JPRN-UMIN000017908
- Lead Sponsor
- Tottori University Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 15
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Endometriosis QOL questionnaire EHP-30 (Endometriosis Health Profile-30)
- Secondary Outcome Measures
Name Time Method