UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and Safety of Sansoninto in Insomnia with Psychiatric Disorder: An Open-Label Study
Acronym	Sansoninto in Insomnia with Psychiatric Disorder
Scientific Title	Efficacy and Safety of Sansoninto in Insomnia with Psychiatric Disorder: An Open-Label Study
Scientific Title:Acronym	Sansoninto in Insomnia with Psychiatric Disorder
Region	Japan

Condition
Condition	Insomnina with Psychiatric Disorder
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The efficacy and safety of sansoninto was examined in adult psychiatric disorder patients with insomnia symptoms.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	PSQI
Key secondary outcomes	ISI, AIS, CGI-I

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Sansouninto Treatment
Interventions/Control_2	No treatment
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	The subjects enrolled in the study were patients with psychiatric disorders, raging 27-80 years of age, with PSQI of greater than six. These patients 45 minutes or more failing asleep, slept less than six hours, and struggled with this issue continously for at least one month.
Key exclusion criteria	1) within three months of the study there had been a major incident. 2) working the nightshift. 3) lack of time or tining conflicts.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tsuyoshi Miyaoka
Organization	Shimane University School of Medicine
Division name	Psychiatry
Zip code
Address	Enyacho 89-1
TEL	0853-20-2262
Email	miyanyan@med.shimane-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Tsuyoshi Miyaoka
Organization	Shimane University School of Medicine
Division name	Psychiatry
Zip code
Address	Enyacho 89-1
TEL	0853-20-2262
Homepage URL
Email	miyanyan@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University School of Medicine, Department of Psyvhiatry
Institute
Department

Funding Source
Organization	Shimane University School of Medicine, Department of Psyvhiatry
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 04 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	2010 Year 09 Month 15 Day
Date of IRB
Anticipated trial start date	2011 Year 01 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 06 Month 03 Day
Last modified on	2014 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016484

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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