UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041613 |
|---|---|
| Receipt number | R000047502 |
| Scientific Title | Hyperbaric oxygen therapy versus Risperidone in autistic children: a comparative study |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2020/08/31 03:56:04 |
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Basic information
Public title
Hyperbaric oxygen therapy versus Risperidone in autistic children: a comparative study
Acronym
Hyperbaric oxygen therapy versus Risperidone in autism
Scientific Title
Hyperbaric oxygen therapy versus Risperidone in autistic children: a comparative study
Scientific Title:Acronym
Hyperbaric oxygen therapy versus Risperidone in autism
Region
| Africa |
Condition
Condition
Autism spectrum disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We postulate that children with autism spectrum disorder receiving Hyperbaric oxygen therapy and Risperidone will make improvements in the core symptoms. We will examine the improvements of symptoms by CARS and ATEC scores for evaluation of autism.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Clinical psychiatric improvement measured by CARS and ATEC before and after administration.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A (60):received forty sessions of Hyperbaric oxygen therapy.
Interventions/Control_2
Group B (60):received Risperidone for 6 months.
Interventions/Control_3
Group C (60):No treatment
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
| 5 | years-old | <= |
Age-upper limit
| 8 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children diagnosed ASD by neurologist or psychiatrist based on (DSM-5)
Key exclusion criteria
1. Presence of significant medical problems and any other neuropsychiatric disorder requiring drug therapy (e.g., Bipolar disorder, psychosis).
2. Weight less than 15 kg.
3. Other cardiac, liver, gastrointestinal, renal, endocrine, blood and metabolic diseases.
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Ahmed |
| Middle name | Abdelbaqy |
| Last name | Abdelrahman |
Organization
Faculty of Medicine, Assiut University, Assiut, Egypt.
Division name
neuropsychiatry
Zip code
71515
Address
Assiut, Egypt
TEL
+0201096477803
ahmedbaki220@yahoo.com
Public contact
Name of contact person
| 1st name | Hosam |
| Middle name | Mohammad |
| Last name | Ahmad |
Organization
Egypt Ministry of Health and population
Division name
Internal Medicine and biomedical chemistry
Zip code
61516
Address
Minia, Egypt
TEL
+0201000638308
Homepage URL
hosam.refaei@yahoo.com
Sponsor or person
Institute
Minia University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Minia university
Address
Minia, Egypt
Tel
020862347759
vp.pg@mu.edu.eg
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
"Minia university, minia and Assiut university hospital"
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.minia.edu.eg/pharm/
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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 08 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 31 | Day |
Last modified on
| 2020 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047502
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| Registered date | File name |
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| Registered date | File name |
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