UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027957 |
|---|---|
| Receipt number | R000032027 |
| Scientific Title | A study of efficacy of yokukansankachinpihange for premenstrual syndrome (PMS) |
| Date of disclosure of the study information | 2017/06/28 |
| Last modified on | 2017/06/28 00:06:46 |
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Basic information
Public title
A study of efficacy of yokukansankachinpihange for premenstrual syndrome (PMS)
Acronym
A study of efficacy of yokukansankachinpihange for premenstrual syndrome (PMS)
Scientific Title
A study of efficacy of yokukansankachinpihange for premenstrual syndrome (PMS)
Scientific Title:Acronym
A study of efficacy of yokukansankachinpihange for premenstrual syndrome (PMS)
Region
| Japan |
Condition
Condition
premenstrual syndrome (PMS)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Questionnaire survey related to QOL will be conducted for patients taking yokukansankacinpihange for PMS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Menstrual Distress Questionnaires MDQ
Key secondary outcomes
SF-8
VAS
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
patients who complain of irritability diagnosed as PMS by criteria of ACOG practice bulletin 2000
Key exclusion criteria
1.Patients taking hormonal drugs, antipsychotic drugs, or kampo within 2 months before the start of the study
2.Patients diagnosed with other psychiatric disorders
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomomi Nakamura |
Organization
yokohama city university hospital
Division name
Gynecology
Zip code
Address
Fukuura3-9, Kanagawa, Yokohama, Kanagawa, Japan
TEL
045-787-2800
tomominn-i1483@nifty.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taku Tsuburai |
Organization
Yokohama City University Hospital
Division name
Gynecology
Zip code
Address
Fukuura3-9, Kanagawa, Yokohama, Kanagawa, Japan
TEL
045-787-2800
Homepage URL
tsubutsububuu@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Hospital
Organization
Division
Category of Funding Organization
Self funding
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
横浜市立大学附属病院（神奈川）、後藤産婦人科（神奈川）、よしかた産婦人科（神奈川）、ユノクリニック（神奈川
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 28 | 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
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 06 | Month | 28 | Day |
Last modified on
| 2017 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032027
