CTRI Number |
CTRI/2022/06/043459 [Registered on: 23/06/2022] Trial Registered Prospectively |
Last Modified On: |
06/11/2023 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Behavioral |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
An interventional study to assess the effect of spiritual therapy in the treatment of autistic children |
Scientific Title of Study
|
Prospective , single center interventional study to assess the effect of spiritual therapy in the treatment of autistic children |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Omkar Hajirnis |
Designation |
Pediatrician |
Affiliation |
Bhaktivedanta Hospital and Research Institute |
Address |
Department of Pediatric Neurologist, first floor OPD room number 6, Bhaktivedanta Swami Marg, Sector 1, Srishti Complex, Mira Road, Maharashtra 401107
Thane MAHARASHTRA 401107 India |
Phone |
9869271683 |
Fax |
|
Email |
dr.omkar@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Omkar Hajirnis |
Designation |
Pediatrician |
Affiliation |
Bhaktivedanta Hospital and Research Institute |
Address |
Department of Pediatric Neurologist, first floor OPD room number 6, Bhaktivedanta Swami Marg, Sector 1, Srishti Complex, Mira Road, Maharashtra 401107
Thane MAHARASHTRA 401107 India |
Phone |
9869271683 |
Fax |
|
Email |
dr.omkar@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Omkar Hajirnis |
Designation |
Pediatrician |
Affiliation |
Bhaktivedanta Hospital and Research Institute |
Address |
Department of Pediatric Neurologist, first floor OPD room number 6, Bhaktivedanta Swami Marg, Sector 1, Srishti Complex, Mira Road, Maharashtra 401107
Thane MAHARASHTRA 401107 India |
Phone |
9869271683 |
Fax |
|
Email |
dr.omkar@gmail.com |
|
Source of Monetary or Material Support
|
Bhaktivedanta Hospital and Research Institute |
|
Primary Sponsor
|
Name |
Bhaktivedanta Hospital and Research Institute |
Address |
Bhaktivedanta Swami Marg, Sector 1, Srishti Complex, Mira Road, Maharashtra 401107 |
Type of Sponsor |
Research institution and hospital |
|
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 |
Dr Omkar Hajirnis |
Bhaktivedanta Hospital and Research Institute |
Department of Pediatric Neurologist, first floor OPD room number 6, Bhaktivedanta Swami Marg, Sector 1, Srishti Complex, Mira Road, Maharashtra 401107 Thane MAHARASHTRA |
9869271683
dr.omkar@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Bhaktivedanta Hospital and Research Institute Ethics Committee |
Approved |
Bhaktivedanta Hospital and Research Institute Ethics Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Spiritual therapy |
occupational therapy, sensory integration and spiritual therapy in form of mantra chanting tapes (In awake/sleep, total 30 minutes twice a day for 6 months) along with no screen exposure advise. . Bhaktivedanta Audiotherapy will include
A) MANTRAS:
1) Srila Prabhupada chanting hare krishna mantra.
2) Adityhridayakavacham prayer to sun god who gives good health and intelligence.
3) Dhanvantari mantra.
B) Shloka recitation of 9th chapter of Bhagwad Gita by Radha Gopinath prabhu- sanskrit language stimulates brain
C) Raga Shivaranjani and Raga Shankarbharnam
|
Comparator Agent |
Standard of care |
Patients will be identified in pediatric neurology OPD, referred to psychologist and diagnosed by DSM-5 criteria. CARS, DQ, Attention deficit hyperactivity disorder (ADHD ) quotient will be done as standard of care |
|
Inclusion Criteria
|
Age From |
2.00 Year(s) |
Age To |
18.00 Year(s) |
Gender |
Both |
Details |
1. Any child aged 2 to 18 years, diagnosed Autism spectrum disorder by DSM- 5 criteria with severity grading done using CARS score will be enrolled. |
|
ExclusionCriteria |
Details |
1. Children with autism with developmental delay will be excluded.
2. The cases which fulfills DSM-5 criteria of ASD incompletely.
3. Autistic children with hearing defect.
4. Children with major chromosomal defect or with neuro-structural defect.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To study difference in Childhood Autism Rating Scale (CARS) of autistic children treated by traditional occupational therapy with or without spiritual therapy. |
Visit 1 months, 3 months, 6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
To study difference in developmental quotient (DQ) and Attention-deficit/hyperactivity disorder (ADHD) quotient of autistic children treated by traditional occupational therapy with or without spiritual therapy.
|
Visit 1 months, 3 months, 6 months |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
01/07/2022 |
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="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Autism spectrum disorder (ASD) is a neurobiological disorder with onset in early childhood. The main features are impairment in social communication and social interaction accompanied by restricted and repetitive behaviors starting from early developmental period. The cause of ASD is thought to result from disrupted neural connectivity and is primarily impacted by genetic variations affecting early brain development. Many environmental and epigenetic models have been described too. This is spectrum of disorder hence presentation varies significantly from one individual to another, as well as over the course of development for a particular child. There is no diagnostic biochemical test for ASD. Diagnosis is therefore based on careful review of the history and direct observation of the child’s behavior, is done by using DSM-5 criteria of ASD. After more than 20 years of committed research in autism, there is ample reason to pursue alternative solutions to treatment. Prospective studies have generally found that 60–75 percent of individuals with autism followed into adulthood experience poor or very poor outcomes. There is also no effective medication for autism. Risperidone, the only FDA-approved drug for the treatment of altered behaviors in autism, has known adverse effects and is only indicated for moderate-to-severe behavioral problems associated with autism since there is no clear benefit in treating core symptoms. Yogis and eastern physicians knew of the existence of the circulatory and endocrine systems and circadian rhythms as early as the 6th century BC [46, 104, 105] and describe a more refined level of signaling in organisms at 5 physical and atomic level than the chemical and molecular known to modern medicine today [42, 46, 106]. (example, verses 1–12 of the Mandukya Upanishad describes four levels of consciousness from waking to pure consciousness, and nineteen channels: four functions of mind, which are manas, chitta, ahamkara, and buddhi, that operate through five pranas (prana, apana, samana, udana, and vyana), the five active senses and the five cognitive senses.) Rather than ignoring this vast amount of information and the millenary arts from it derived, it is naturally desirable to yield these principles to scientific rigor to understand them. Mantra Meditation creates a one-pointed mind that helps restore the coherence of the human system and as well as harness energy to overcome physical and psychological challenges. As a complementary approach to personalized medical care and conventional therapies, mantra meditation has shyly made its way into several clinical settings and has undergone unprecedented scientific research in the last few years. Chanting mantra remains a part of many traditions and lineages of practice today. These patterns are used as catalysts of meditative states and Samadhi (pure consciousness) because of their perfected rhythm, sound, tone, focus, and meaning. This is not uncharted territory since it is known that musical beats have entraining power. For example, it is well documented that slow-tempo musical pieces induce delta brainwaves and sleep. It is also known that language, music, and singing share functional networks and therefore singing and music may compensate for deficiencies in language. According to the National Autism Center, music therapy is an emerging intervention used for people with ASD. Music therapy is used to improve a variety of skills, including social skills, communication, motor/sensory ability, and cognitive functioning. Music therapy can help students with ASD express themselves in new ways. It can provide opportunities for people with ASD to connect with other people, ease anxiety, and promote self-expression. Music is multi-sensory which helps to enhance processing and motor skills. Music therapy techniques and specific teaching strategies can be individualized to meet specific needs, preferences, family values, beliefs, and priorities. Bhaktivedanta Audio therapy includes hearing of powerful mantras and music therapy in specific raga s to improve cognitive brain function and our attempt is to correlate its effects on children affected with Autism spectrum disorders.
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