| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F840||Autistic disorder. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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 | | 2 | Intervention Arm | Drug | Classical | | (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 |