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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000014156 |
Receipt No. | R000016484 |
Scientific Title | Efficacy and Safety of Sansoninto in Insomnia with Psychiatric Disorder: An Open-Label Study |
Date of disclosure of the study information | 2014/06/04 |
Last modified on | 2014/06/03 |
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 |
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Condition | ||
Condition | Insomnina with Psychiatric Disorder | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Shimane University School of Medicine | ||||||
Division name | Psychiatry | ||||||
Zip code | |||||||
Address | Enyacho 89-1 | ||||||
TEL | 0853-20-2262 | ||||||
miyanyan@med.shimane-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Shimane University School of Medicine | ||||||
Division name | Psychiatry | ||||||
Zip code | |||||||
Address | Enyacho 89-1 | ||||||
TEL | 0853-20-2262 | ||||||
Homepage URL | |||||||
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 | |
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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 |
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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 | |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |