UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015708 |
|---|---|
| Receipt number | R000018259 |
| Scientific Title | Efficacy and Safety of Yokukansan in Autism Spectrum disorder: A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial |
| Date of disclosure of the study information | 2014/11/17 |
| Last modified on | 2014/11/17 17:31:43 |
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Basic information
Public title
Efficacy and Safety of Yokukansan in Autism Spectrum disorder:
A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial
Acronym
Efficacy and safety of yokukansan in autism spectrum disorder
Scientific Title
Efficacy and Safety of Yokukansan in Autism Spectrum disorder:
A Randomized, Multi-center, Double-Blind, Placebo-Controlled Trial
Scientific Title:Acronym
Efficacy and safety of yokukansan in autism spectrum disorder
Region
| Japan |
Condition
Condition
Autism Spectrum Disorder
Classification by specialty
| Pediatrics | Psychiatry | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate the efficacy and tolerability of Yokukansan as an add-on pharmacotherapy for clinical symptoms in patients with Autism Spectrum Disorder over a 12-week period.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Aberrant behavior checklist
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention: Yokukansan
Interventions/Control_2
Control: Placebo
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
| 6 | years-old | <= |
Age-upper limit
| 17 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
DSM-V: Autism Spectrum Disorder
ABC-I: > 18
CGI-S: > 4
Key exclusion criteria
Presence of any active medical condition, diagnosis of any other psychiatric disorder on the DSM-5, use of any psychotropic medication in the six weeks prior to the baseline visit and history of hepatic disease or seizure could exclude the subject from this study.
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
89-1, Enyacho, Izumo
TEL
0853-20-2262
miyanyan@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiko Yano |
Organization
Shimane University School of Medicine
Division name
Psychiatry
Zip code
Address
89-1, Enyacho, Izumo
TEL
0853-20-2262
Homepage URL
book47@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shimane University School of Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
Shimane University School of Medicine
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 11 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 25 | Day |
Date analysis concluded
| 2017 | Year | 02 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 17 | Day |
Last modified on
| 2014 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018259
