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CTRI Number  CTRI/2025/08/092350 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 02/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Ayurvedic management in the socio behavioral domains of autism in children  
Scientific Title of Study   Combined effect of Mahapaishachika ghritham and Balasohaladi shirolepam against Kalyanaka ghritham and Brahmisohaladi shirolepam in the socio -behavioral domains of autism in children- A randomized controlled trial 
Trial Acronym  RCT in ASD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sreedivya 
Designation  Associate Professor 
Affiliation  Government Ayurveda College, Kannur 
Address  Department of Kaumarabhritya Government Ayurveda College, Kannur-670503

Kannur
KERALA
670503
India 
Phone  9497292474  
Fax    
Email  sridivya_ram@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sreedivya 
Designation  Associate Professor 
Affiliation  Government Ayurveda College, Kannur 
Address  Department of Kaumarabhritya Government Ayurveda College, Kannur-670503


KERALA
670503
India 
Phone  9497292474  
Fax    
Email  sridivya_ram@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Sreedivya 
Designation  Associate Professor 
Affiliation  Government Ayurveda College, Kannur 
Address  Department of Kaumarabhritya Government Ayurveda College, Kannur-670503


KERALA
670503
India 
Phone  9497292474  
Fax    
Email  sridivya_ram@yahoo.co.in  
 
Source of Monetary or Material Support  
CENTRE OF EXCELLENCE FOR DISABILITY STUDIES LBS ITW CAMPUS, POOJAPPURA, THIRUVANANTHAPURAM-695012.  
 
Primary Sponsor  
Name  CENTRE OF EXCELLENCE FOR DISABILITY STUDIES LBS ITW CAMPUS, POOJAPPURA, THIRUVANANTHAPURAM-695012. 
Address  CENTRE OF EXCELLENCE FOR DISABILITY STUDIES LBS ITW CAMPUS, POOJAPPURA, THIRUVANANTHAPURAM-695012.  
Type of Sponsor  Government funding agency 
 
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 Sreedivya  Government Ayurveda College, Kannur  Department of Kaumarabhritya, A Block 1st floor, GAC, Pariyaram Kannur- 670503
Kannur
KERALA 
9497292474

sridivya_ram@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC Government Ayurveda College Kannur   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
1Comparator ArmDrugClassical(1) Medicine Name: KALLYANAKA GHRITA, Reference: ASTANGA HRIDAYA, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -HOT WATER), Additional Information: -NIL
(2) Medicine Name: BRAHMISOHALADI SHIROPLEPAM, Reference: AKD, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 75(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -NIL
2Intervention ArmDrugClassical(1) Medicine Name: MAHAPAISHACHIKA GHRITA, Reference: ASHTANGA HRIDAYA, Route: Oral, Dosage Form: Ghrita, Dose: 10(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -HOT WATER), Additional Information: -
(2) Medicine Name: BALASOHALADI SHIROLEPAM, Reference: AKD, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 75(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children between 3-12 years with Autism, satisfying DSM- V criteria having a Childhood Autism Rating Scale (CARS) score above 30. 
 
ExclusionCriteria 
Details  All other Pervasive development disorders will be excluded by thorough clinical evaluation.
Tuberous sclerosis, Neurofibromatosis, Fragile x syndrome, Phenylketonuria
Recurrent Respiratory Tract Infections
Seizure disorders
Children with other developmental disorders
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessments will be done before therapy (baseline; on the first day), after therapy (31th day) and after the follow up period (of 30 days). Outcome measurement will be mainly done with VSMS, VDPRS and Autism treatment Evaluation Checklist before and after treatment   Assessments will be done before therapy (baseline; on the first day), after therapy (31th day) and after the follow up period (of 30 days). Outcome measurement will be mainly done with VSMS, VDPRS and Autism treatment Evaluation Checklist before and after treatment  
 
Secondary Outcome  
Outcome  TimePoints 
VSMS,VDPRS,ATEC  Baseline, 30 days and follow up period of 30 days  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   21/08/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Autism is a neurodevelopmental disorder which first appears during infancy or childhood. It generally, follows a steady course without remission. Overt symptoms gradually begin after the age of six months, become established by age two or three years and tend to continue through adulthood. The prevalence of autism is 0.2% in India.  Regardless of the level of intelligence, all autistic children share basic disturbances in social interaction and communication which reduces the quality of life of both the individual and the child’s family. Thus, any treatment modality which has the capacity to treat behavioral problems, such as aggression, self-injurious behavior, and severe tantrums are helpful in improving the functioning of autistic persons at home or school. It is a challenge to the contemporary science to manage autism with its existing management protocol of Behavioral therapy. Many researches and claims in autistic research have results which are not very promising. 

Mahapaishachika ghrita, Balasohaladi yogam and shirolepam are safe, effective and time-tested drugs commonly used for neuro psychiatric disorders in children. The increasing prevalence of Autism, its impact on the socio behavioral patterns in children and the lack of effective evidence based therapeutic intervention makes the study significant. It will be an open label, randomized controlled clinical trial. Children with Autism aged 3-12 years will be selected from an accessible population attending the Out Patient Department of Govt. Ayurveda College Hospital, Kannur and those satisfying the inclusion criteria will be recruited for the trial and randomly allocated into study and control groups

 
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