UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study of efficacy of yokukansankachinpihange for premenstrual syndrome (PMS)
Title of the study (Brief title)	A study of efficacy of yokukansankachinpihange for premenstrual syndrome (PMS)
Region	Japan

Condition
Condition	premenstrual syndrome (PMS)
Classification by specialty	Obsterics 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	Tomomi Nakamura
Organization	yokohama city university hospital
Division name	Gynecology
Address	Fukuura3-9, Kanagawa, Yokohama, Kanagawa, Japan
TEL	045-787-2800
Email	tomominn-i1483@nifty.com

Public contact
Name of contact person	Taku Tsuburai
Organization	Yokohama City University Hospital
Division name	Gynecology
Address	Fukuura3-9, Kanagawa, Yokohama, Kanagawa, Japan
TEL	045-787-2800
Homepage URL
Email	tsubutsububuu@yahoo.co.jp

Sponsor
Institute	Yokohama City University Hospital
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032027