UMIN-CTR Clinical Trial

Basic information
Public title	The evaluation of the efficacy and the safety of TSUMURA Tokishakuyakusan Extract Granules for Ethical Use on endometriosis patients with dysmenorrhea
Acronym	The effect of Tokishakuyakusan on endometriosis patients with dysmenorrhea
Scientific Title	The evaluation of the efficacy and the safety of TSUMURA Tokishakuyakusan Extract Granules for Ethical Use on endometriosis patients with dysmenorrhea
Scientific Title:Acronym	The effect of Tokishakuyakusan on endometriosis patients with dysmenorrhea
Region	Japan

Condition
Condition	Endometriosis
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the treatment satisfaction improvement effect of Tokishakuyakusan in endometriosis patients who is taking low dose estrogen progestin(LEP)and still have dysmenorrhea or malaise, while collecting safety information.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Endometriosis QOL questionnaire EHP-30 (Endometriosis Health Profile-30)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	TSUMURA Tokishakuyakusan Extract Granules for Ethical Use Oral administration 7.5g/day in 2 or 3 divided doses before or between meals.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key 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
Key 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
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tasuku Harada
Organization	Tottori University Faculty of Medicine
Division name	Division of Reproductive-Perinatal Medicine and Gynecologic Oncology, Department of Surgery
Zip code
Address	36-1Nishi-cho,Yonago 683-8504,Japan
TEL	0859-38-6647
Email	tasuku@med.tottori-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Fuminori Taniguchi
Organization	Tottori University Faculty of Medicine
Division name	Division of Reproductive-Perinatal Medicine and Gynecologic Oncology, Department of Surgery
Zip code
Address	36-1Nishi-cho, Yonago 683-8504,Japan
TEL	0859-38-6647
Homepage URL
Email	tani4327@med.tottori-u.ac.jp

Sponsor
Institute	Tottori University Faculty of Medicine
Institute
Department

Funding Source
Organization	TSUMURA and CO.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	鳥取大学医学部附属病院（鳥取県）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 05 Month 26 Day
Date of IRB	2017 Year 02 Month 07 Day
Anticipated trial start date	2015 Year 07 Month 06 Day
Last follow-up date	2018 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 06 Month 15 Day
Last modified on	2019 Year 12 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020750