| CTRI Number |
CTRI/2026/01/102143 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Pilot Study To Evaluate The Clinical Efficacy Of Siddha Varmam Therapy In Autism Spectrum Disorder |
|
Scientific Title of Study
|
A Pilot Study to Evalutae the Therapeutic Efficacy of Siddha Varmam therapy in Autism Spectrum Disorder |
| Trial Acronym |
Siddha varmam therapy in Autism Spectrum Disorder |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR R Revathy |
| Designation |
Assistant Medical officer Siddha |
| Affiliation |
Arignar Anna Government Hospital of Hospital of Indian Medicine, Arumbakkam, Chennai 106 |
| Address |
Department Of Varmam
Arignar Anna Government Hospital of Indian Medicine
Arumbakkam
chennai
Arignar Anna Government Hospital of indian medicine
Arumbakkam
Chennai 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9840512810 |
| Fax |
|
| Email |
drrevathymd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr TR Siddique ali |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate department of Varmam Maruthuvam
Government Siddha Medical College
arumbakkam
Director Incharge
Arignar Anna Government Hospital Of Indian Medicine
Arumbakkam
Chennai 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
09962019900 |
| Fax |
|
| Email |
tkrsiddique@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr TR Siddique ali |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College |
| Address |
Post Graduate department of Varmam Maruthuvam
Government Siddha Medical College
Arumbakkam
Chennai
Director Incharge
Arignar Anna Government Hospital of Indian Medicine
Arumbakkam
Chennai
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
09962019900 |
| Fax |
|
| Email |
tkrsiddique@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrRRevathy |
| Address |
Arignar Anna Government Hospital of Indian Medicine
Arumbakkam
Chennai 600106
Chennai 600106 |
| Type of Sponsor |
Other [] |
|
|
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 R Revathy |
Arignar Anna Government Hospital of Indian Medicine |
Arignar Anna Government Hospital of Indian Medicine
Arumbakkam
Chennai 600106
Chennai
TAMIL NADU |
09840512810
drrevathymd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F59||Unspecified behavioral syndromes associated with physiological disturbances and physical factors, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Siddha Varmam Therapy |
All Patients Satisfying Inclusion Criteria Will be Given Varmam Therapy Weekly Once For 8 Weeks |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Age 2 TO 12 Years
Sex Both male and Female children
Children having Lack of eye contact
Lack of Response
Repititive or restricted Behaviour
Unaware of natural urges
Acquired speech or lost it
Unusual sensitive to sensory stimuli
|
|
| ExclusionCriteria |
| Details |
Children above 12 years and below 2 years
Severe and Recurrent seizures
ADHD
Cerebral palsy
Infantile hemiplegia
Congenital anamolies
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome is assessed by reduction of the clinical symptoms |
Outcome is assessed by reduction scores in Scale of Indian Scale of Assesment of Autism measured weekly once for 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| outcome will be assesed by reduction of clinical symptoms |
outcome is mainly assesed using scores from Indian Scale for assesment of Autism before & after treatment in the basis of weekly 1 time for 8 weeks
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
04/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/02/2026 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The study protocol is designed to systematically evaluate the thereupeutic efficacy of siddha varmam therapy in the management of Autism spectrum disorder by integreating traditional siddha principles with standardized clinical assesments |