UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The examination of the utility of the Yokukansan for the insomnia to fibromyalgia
Title of the study (Brief title)	The examination of the utility of the Yokukansan for the insomnia to fibromyalgia
Region	Japan

Condition
Condition	The fibromyalgia patients with insomnia
Classification by specialty	Medicine in general Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigation for the utility to the Yokukansan for the insomnia of fibromyalgia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Japanses Pittsburgh Sleep Quality Index(PSQI)
Key secondary outcomes	Japanses Fibromyalgia Impact Questionnaire Japanses State-Trait Anxiety Inventory

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Remedy for Yukukannsan
Interventions/Control_2	Not remedy for Yukukannsan
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) The paients of fybromyalgia for 1990 American College of Rheumatology diagnostic criteria. 2)Japanese Pittsburgh Sleep Quality Index point was over 6.
Key exclusion criteria	The patients with depression or dementia
Target sample size	60

Research contact person
Name of lead principal investigator	Kenichi Osada
Organization	St. Marianna University School of Medicine
Division name	Neuropsychiatry
Address	2-16-1, Sugao Miyamae-ku, Kawasaki, Japan
TEL	044-977-8111
Email

Public contact
Name of contact person	Kenichi Osada
Organization	St. Marianna University School of Medicine
Division name	Neuropsychiatry
Address
TEL	044-977-8111
Homepage URL
Email

Sponsor
Institute	St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization	St. Marianna University School of Medicine
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

Other administrative information
Date of disclosure of the study information	2011 Year 11 Month 21 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 11 Month 21 Day
Anticipated trial start date	2011 Year 12 Month 01 Day
Last follow-up date
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

Management information
Registered date	2011 Year 11 Month 11 Day
Last modified on	2017 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007924