| CTRI Number |
CTRI/2023/01/049014 [Registered on: 16/01/2023] Trial Registered Prospectively |
| Last Modified On: |
06/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing and Validation of combined Yoga and Ayurveda program for Autism Spectrum Disorder |
|
Scientific Title of Study
|
Content Validation And Feasibility Of An Integrated Yoga And Ayurveda Based Intervention for Autism Spectrum Disorder |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| N/A |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P Sai Manoj |
| Designation |
Doctor |
| Affiliation |
National Institute of Mental Health and Neuroscience |
| Address |
Cabin no 2, 1st floor, NIMHANS Integrated center for Yoga, Department of Integrative Medicine NIMHANS
Bangalore
KARNATAKA
560029
India |
| Phone |
7842296450 |
| Fax |
|
| Email |
p.saimanoj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh C |
| Designation |
Assistant Professor |
| Affiliation |
NIMHANS |
| Address |
Room no 3,Ground floor, Department of Integrative Medicine NIMHANS
Bangalore
KARNATAKA
560029
India |
| Phone |
9480815976 |
| Fax |
|
| Email |
drumeshayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Lakshmi Nishitha J |
| Designation |
Scientist B |
| Affiliation |
NIMHANS |
| Address |
Room no F-6, 1st floor, NIMHANS Integrated center for Yoga, Department of Integrative Medicine NIMHANS
Bangalore
KARNATAKA
560029
India |
| Phone |
9480815974 |
| Fax |
|
| Email |
nishitha.jasti910@gmail.com |
|
|
Source of Monetary or Material Support
|
| Integrative centre for Yoga, Department Integrative medicine, cabin 2,NIMHANS, Bangalore |
|
|
Primary Sponsor
|
| Name |
Dr P Sai Manoj |
| Address |
Cabin no 2, 1st floor, NIMHANS Integrated center for Yoga, Department of Integrative Medicine NIMHANS |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| P Sai Manoj |
NIMHANS |
Department of Integrative Medicine, Integrated center for Yoga, Cabin no 2
Bangalore
KARNATAKA |
7842296450
p.saimanoj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee for Research in AYUSH and Integrative Medicine |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F840||Autistic disorder. Ayurveda Condition: BALAROGAH-SANKIRNA, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | bastikarma, बसà¥à¤¤à¤¿à¤•à¤°à¥à¤® | (Procedure Reference: Charaka Samhita, Procedure details: Niruha basti with erandamoola kashaya
Anuvasana basti with shuddha bala taila
Duration for 8 days)
(1) Medicine Name: Erandamoola yapana basti, Reference: charaka samhita, Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 250(ml), Frequency: od, Duration: 8 Days | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: Yoga Session- 6 sessions/week-45 minutes/session-18 sessions in total , Ritucarya: , Acara Rasayana:, Other:, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
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Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Social quotient- above 60%
Diagnosis of Autism according to DSM 5, INCLEN Diagnostic Tool
Children with mild autism
Children with or without aggression
Children with or without ADHD
Parents education - Metric
Children with or without Psychotropics |
|
| ExclusionCriteria |
| Details |
Neurological disorders of known etiology
Significant sensory or motor impairment
Major physical abnormalities
History of head injuries
Children in any neurotrophic medications |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Autism Treatment and Evaluation Checklist ( ATEC)
|
At baseline and after 3 weeks of intervention |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Composite sleep disturbance index (CSDI)
Gastrointestinal severity Index (GSI)
Yoga Performance Assessment scale (YPA)
|
At baseline and after 3 weeks of intervention |
|
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Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
20/01/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/01/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Autism Spectrum Disorder(ASD) remains to de one of the lifelong disorders which doesn’t have a definitive cure. This causes lot of distress in child as well as the care givers with significant deterioration in their quality of life. The conventional therapies also has limited evidence in treating these children. Yoga therapy in the recent times has shown to have promising results in terms of improving several domains of ASD if done systematically and regularly for a long term. Similarly Ayurveda has also shown efficacy in few reported case studies. However, a combined modality of treatment including both components of Yoga and Ayurveda has been sparse. Objective: To validate safe and feasible Integrated Yoga and Ayurveda Module (IYAM) for autism spectrum disorder with an objective of improving physical, social and emotional disturbances in ASD children and to test the feasibility IYAM . NULL HYPOTHESIS: 1. The developed integrated module will not be safe and feasible for practice in patients suffering from ASD in a pilot study. 2. The developed integrated yoga and Ayurveda module will not have positive effect on physical, social and emotional disturbances in ASD children ALTERNATE HYPOTHESIS: 1. The developed integrated module will be safe and feasible for practice in patients suffering from ASD in a pilot study. 2. The developed integrated yoga and Ayurveda module will have positive effect on physical ,social and emotional disturbances in ASD children (with specific regards to social communication and restricted repetitive behaviours, sleep disturbances, GI disturbances sensory impairments Design: Open label pilot study Setting: The trial will be conducted in NIMHANS Integrate Centre for Yoga, NIMHANS. Subjects: Subjects aged 10 years to 18 years both male and female diagnosed as ASD, satisfying the inclusion criteria would be included in the study. Interventions: An Integrated Yoga and Ayurveda Management Program will be administered. Assessments: Autism Treatment Evaluation Checklist (ATEC), Composite Sleep Disturbance Index(CSDI), Gastrointestinal Severity Index(GSI), Yoga Performance Assessment(YPA)
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