UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017908 |
|---|---|
| Receipt number | R000020750 |
| Scientific Title | The evaluation of the efficacy and the safety of TSUMURA Tokishakuyakusan Extract Granules for Ethical Use on endometriosis patients with dysmenorrhea |
| Date of disclosure of the study information | 2015/06/15 |
| Last modified on | 2019/12/16 19:07:50 |
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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
| Obstetrics 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
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
tani4327@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University Faculty of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020750
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