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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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