| CTRI Number |
CTRI/2018/08/015267 [Registered on: 10/08/2018] Trial Registered Prospectively |
| Last Modified On: |
08/08/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Yoga for Autistic |
|
Scientific Title of Study
|
Integrated yoga and naturopathy intervention on autistic children: a behavioral and electro-photonic imaging study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepeshwar Singh |
| Designation |
Assistant Professor |
| Affiliation |
Swami Vivekananda Yoga University (S-VAYSA) |
| Address |
Department of Yoga and Life Sciences, 19 Eknath Bhavna, Gavipuram Circle, K.G. Nagar, Bengaluru.
Bangalore
KARNATAKA
560019
India |
| Phone |
|
| Fax |
|
| Email |
deepeshwar.singh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepeshwar Singh |
| Designation |
Assistant Professor |
| Affiliation |
Swami Vivekananda Yoga University (S-VAYSA) |
| Address |
Department of Yoga and Life Sciences, 19 Eknath Bhavna, Gavipuram Circle, K.G. Nagar, Bengaluru.
Bangalore
KARNATAKA
560019
India |
| Phone |
|
| Fax |
|
| Email |
deepeshwar.singh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Surendra Singh Sankhla |
| Designation |
PhD Scholar |
| Affiliation |
Swami Vivekananda Yoga University (S-VAYSA) |
| Address |
Department of Yoga and Life Sciences, 19 Eknath Bhavan, Gavipuram Circle, K.G. Nagar, Bengaluru
Bangalore
KARNATAKA
560019
India |
| Phone |
9986166748 |
| Fax |
|
| Email |
surendrayoga@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Yoga and Life Sciences, Swami Vivekananda Yoga University (S-VYASA), 19 Eknath Bhavan, Gavipuram Circle, K.G. Nagar, Bengaluru |
|
|
Primary Sponsor
|
| Name |
Swami Vivekananda Yoga University SVYASA |
| Address |
19 Eknath Bhavan, Gavipuram Circle, K.G. Nagar, Bengaluru |
| Type of Sponsor |
Research institution |
|
|
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 |
| Deepeshwar Singh |
Academy for severe handicaps and autism (ASHA) Charitable Trust |
L76A, Kirloskar Colony, 5th Main, 3rd Cross, 4th Block, Bawaveshwar Nagar, Bangalore - 560079
Bangalore
KARNATAKA |
9036367402
deepeshwar.singh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of S-VYASA University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Autistic Spectrum Disorder (ASD) - Autistic Children, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physical Exercie |
It will be also provided for 24 days. Control group participants will be active control. They will receive physical exercise. |
| Intervention |
Yoga Therapy |
Yoga therapy will be provided for 24 Days. It will be consisted of
Physical Posture, Breathing Practices, Relaxation and Cleansing techniques. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1. Children who diagnosed with autistic spectrum disorder under the classification of ICD-10.
2. Age between 08-15 years and diagnosed with autistic in last six months.
3. ASD children who give their consent to attend yoga practice for a minimum period of two months.
4. Children for whom the parents agreed to give their consent. |
|
| ExclusionCriteria |
| Details |
1. Children with prior exposure to yoga,
2. Children with major physical impairments.
3. Children with severe ADHD.
4. Children who are noncooperative behavior |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Behavior related problems
2. Energy Level using Electro Photonic Imaging (EPI) |
Day 1 and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Behavior related changes after yoga intervention |
Day 1 and Day 60 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Previous studies reported that yoga brings positive changes initially at the physical level, then at the mental level. Most of the children’s imitating skills increased during the first few days of intervention which was essential for the learning process and this helped children to practice asanas looking at their parents. Yoga helps ASD children to increase imitating skill was proved in one of the previous studies also (Shantha Radhakrishna, 2010) According to parent’s feedback after one month of intervention most of the children improved in sleep and digestion related problems. During night children slept without any interruption for a longer period compared to pre-intervention, going to bed in the night and getting up from bed in the morning not sleeping during day time were some of the improvements observed and this helped parents and other family members to have good sleep themselves during the night. Some children who were snoring and breathing from the mouth during sleep also stopped. Many children started taking balanced food instead of over eating every time. The pathophysiology of ASD is still unclear and uncertain and there is no specific objective assessment available to diagnose this condition alone. Therefore, it is a need to explore and correlates the biophotonic pattern of EPI with symptoms of ASD. Also, to establish a framework for diagnosis and management of autistic behavior disorder by introducing Yoga and Naturopathy treatment as an effective intervention. |