FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/05/052867 [Registered on: 18/05/2023] Trial Registered Prospectively
Last Modified On: 17/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the additional benefit of Ayurveda treatment along with Behavioral therapy in the management of Autism Spectrum Disorder. 
Scientific Title of Study   Add-On Effect Of Ayurveda Treatment Protocol Along With Behavioral Therapy in the Management OF Autism Spectrum Disorder (ASD) – An Open Label Randomized Controlled Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Praveen Kumar Sharma 
Designation  MD (Ayu) Kaumarabhritya, Ongoing PhD scholar 
Affiliation  All India Institute of Ayurveda 
Address  Room No.406 Department of Kaumarabhritya,4th floor, Academic block, All India Institute of Ayurveda Gautam Puri Mathura road New Delhi
Gautam Puri, Mathura Road, New Delhi
South
DELHI
110076
India 
Phone  9990177803  
Fax    
Email  drpraveensharma1985@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahapatra Arun Kumar 
Designation  Assistant Professor- Kaumarabhritya 
Affiliation  All India Institute of Ayurveda 
Address  Department of Kaumarabhritya, 4th Floor, Academic Block, All India Institute of Ayurveda Gautam Puri Mathura Road New Delhi

South
DELHI
110076
India 
Phone  8506821947  
Fax    
Email  ayuarun@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Praveen Kumar Sharma 
Designation  MD (Ayu) Kaumarabhritya, Ongoing PhD scholar 
Affiliation  All India Institute of Ayurveda 
Address  Room No.406 Department of Kaumarabhritya,4th floor, Academic block, All India Institute of Ayurveda Gautam Puri Mathura road New Delhi

South
DELHI
110076
India 
Phone  9990177803  
Fax    
Email  drpraveensharma1985@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Ayurveda, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Ayurveda, New Delhi 
Address  All India Institute of Ayurveda, Mathura Road, Gautampuri, New Delhi, 110076 
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 Praveen Kumar Sharma  All India Institute of Ayurveda, New Delhi  KB OPD - 208, All India Institute of Ayurveda, Gautampuri Mathura Road New Delhi
South
DELHI 		 9990177803

drpraveensharma1985@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee All India Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F840||Autistic disorder. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Mahapaishachika Ghrita, Reference: Ch.chi.9/48, Route: Oral, Dosage Form: Ghrita, Dose: 6.665(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Ushna Jala), Additional Information: -NIL
(2) Medicine Name: saraswatha churna, Reference: B.R. 24/26, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.67(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -Honey), Additional Information: -NIL
(3) Medicine Name: Chitrakadi Vati, Reference: Ch.chi 15/96, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 82(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: - Ushna Jala), Additional Information: -NIL
2Intervention ArmProcedure-bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म (Procedure Reference: Ch.Si 3/33, Procedure details: Medicated decoction of medicinal herbs is administered through rectal route once daily)
(1) Medicine Name: Bala Taila, Reference: A.H. chi 21/81, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 42 Days
(2) Medicine Name: Dashmoola Kwatha, Reference: Bhav Prakash PK Mishreya Varga Guduchyadi Varga verse 42, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 100(ml), Frequency: od, Duration: 42 Days
(3) Medicine Name: Mahapaishachika Ghrita, Reference: Ch.chi. 9/48, Route: Nasal, Dosage Form: Ghrita, Dose: 2(drops), Frequency: od, Duration: 42 Days
(4) Medicine Name: Hapushadi Yapana Basti , Reference: Ch.Si.12/15, Route: Rectal, Dosage Form: Ksheerpaka, Dose: 108(ml), Frequency: od, Duration: 21 Days
3Intervention ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Behavioral Therapy, Pathya/Apathya:no, Pathya:, Apathya:
4Comparator Arm (Non Ayurveda)-Behavioral TherapyBehavioral Therapy will be provided for 12 weeks (Two 90 minute session per week)
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1.Children between 3-9 years of age fulfilling the diagnostic criteria for mild to moderate form of Autism using Childhood Autism Rating Scale (CARS-2)
2.Parents / Guardian willing to give informed written consent to participate in the study 
 
ExclusionCriteria 
Details  1.Children with severe intellectual disability and diagnosed genetic and metabolic disorders.
2.Children currently on behavior therapy, occupational therapy, speech therapy, autism specific dietary intervention and any complementary and alternate medicine for Autism.
3.Children with chronic ailments like tuberculosis, malignancy, juvenile Diabetes mellitus and any other chronic systemic illness.
4.Children taking anti-epileptic and anti-psychotic drugs. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effectiveness of the Ayurveda Treatment Protocol in reducing the core clinical features i.e. social communication and interaction and restricted, repetitive behaviors of ASD using Childhood Autism Rating Scale (CARS-2).  0 day, 90th day and 180th day 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the behavioral problems i.e. Irritability, Social Withdrawal, Stereotypic behavior, Hyperactivity and inappropriate speech using Aberrant Behavior Checklist.
Changes in the adaptive and social functioning using Vineland Social Maturity Scale. 		 0 day, 90th day and 180th day. 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/07/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drpraveensharma1985@gmail.com].

  6. For how long will this data be available start date provided 15-12-2025 and end date provided 15-10-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by deficits in social communication and interaction, as well as restricted, repetitive behaviors. Globally ASD is one of the fastest emerging neurodevelopmental disorder in young children recognized worldwide as evident from the fact that the global prevalence of Autism was estimated to be 61.9/10,000 in 2012. According to a systemic review, it is estimated that approximately 1 in 100 children are diagnosed with ASD around the world. India is the second largest population dense country with children less than 15 years constituting nearly one-third of the population. Though there is not enough studies available to estimate the prevalence rate of ASD in India, approximations show that more than two million people might be affected with ASD in India.
Methodology: 

STUDY DESIGN: Open Label Randomized Controlled Trial

Study Type

Randomized Controlled Clinical  Trial

Purpose

Treatment

Allocation

Block Randomization

Masking

Open Label

Control

Controlled

Timing

Prospective

End Point

Effectiveness

No. of Groups

Two Groups

Sample size

90 (45 in each group)

Type of analysis

Intention to treat

CRITERIA FOR SELECTION

Children attending the Kaumarabhritya OPD, All India Institute of Ayurveda with features of Autism will be screened using Childhood Autism Rating Scale (CARS-2). Those fulfilling the cutoff scores for mild to moderate form of Autism i.e. 30 to 36.5 will be selected and enrolled in the study.

INCLUSION CRITERIA

•      Children between 3-9 years of age fulfilling the diagnostic criteria for mild to moderate form of Autism using Childhood Autism Rating Scale (CARS-2).

 

•       Parents / Guardian willing to give informed written consent to participate in the study.

 

EXCLUSION CRITERIA

•      Children with severe intellectual disability and diagnosed genetic and metabolic disorders.

•      Children currently on behavior therapy, occupational therapy, speech therapy, autism specific dietary intervention and any complementary and alternate medicine for Autism.

•      Children with chronic ailments like tuberculosis, malignancy, juvenile Diabetes mellitus and any other chronic systemic illness.

Children taking anti-epileptic and anti-psychotic drugs.

INTERVENTION IN TRIAL GROUP

S.NO

GROUP A

1.

MAHAPAISHACHIKA GHRITA

Orally for 12 weeks

2.

SARASWATHA CHOORNA

Orally for 12 weeks

3.

CHITRAKADI VATI

Orally for 12 weeks

4.

HAPUSHA YAPANA BASTI(Medicated Enema)

21 days (3 cycles of 7 days each)

5.

NASYA (Nasal administration of Mahapaishachika Ghrita)

42 days (3 cycles of 14 days each)

6.

BEHAVIOR THERAPY

(Applied Behavior Analysis)

12 weeks (Two 90 minute session per week )

INTERVENTION IN CONTROL GROUP

S.NO

GROUP B

1.

BEHAVIOR THERAPY

(Applied Behavior Analysis)

12 weeks (Two 90 minute session per week )

PARAMETER FOR ASSESSMENT OF STUDY OUTCOMES         

A.    PRIMARY OUTCOMES

 

Effect of the Ayurveda Treatment Protocol in reducing the core clinical features i.e. social communication and interaction and restricted, repetitive behaviors of ASD using Childhood Autism Rating Scale (CARS-2). (Timeframe: 0 day, 90th day and 180th day).

A.    SECONDARY OUTCOMES

 

a)      Changes in the behavioral problems i.e. Irritability, Social Withdrawal, Stereotypic behavior, Hyperactivity and inappropriate speech using Aberrant Behavior Checklist. (Timeframe: 0 day, 90th day and 180th day).

b)      Changes in the adaptive and social functioning using Vineland Social Maturity Scale. (Timeframe: 0 day, 90th day and 180th day).

FOLLOW UP: 3 month at the end of completion of intervention.


 
Close