| CTRI Number |
CTRI/2025/08/093378 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Behavioral |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Study to assess the effect Shirodhara and Suvarnaprashan in Autism in Children |
|
Scientific Title of Study
|
Clinical Trial to Access the Efficacy of Shirodhara & Suvarnaprasan in Autism & Establishment of Center for Autism |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shekhar Singh |
| Designation |
PG Scholar |
| Affiliation |
Institute Of Medical Science Banaras Hindu University Varanasi |
| Address |
Department of kaumarbhritya Balarog Faculty Of Ayurveda Institute Of Medical Science Banaras Hindu University Varanasi UTTAR PRADESH 221005 India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8050418942 |
| Fax |
|
| Email |
shekhar.singh8193shakhu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr kalpana Patni |
| Designation |
Assistant Professor |
| Affiliation |
Institute Of Medical Science Banaras Hindu University Varanasi |
| Address |
Department of kaumarbhritya Balarog Faculty Of Ayurveda Institute Of Medical Science Banaras Hindu University Varanasi UTTAR PRADESH 221005 India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9456140578 |
| Fax |
|
| Email |
kalpana.patni@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Patni |
| Designation |
Assistant Professor |
| Affiliation |
Institute Of Medical Science Banaras Hindu University Varanas |
| Address |
Department of kaumarbhritya Balarog Faculty Of Ayurveda Institute Of Medical Science Banaras Hindu University Varanasi UTTAR PRADESH 221005 India
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9456140578 |
| Fax |
|
| Email |
kalpana.patni@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Kumarbhritya / Balroga OPD No 25 Indian Medicine Wing Sir Sunderlal Hospital IMS BHU
Varanasi - 221005
|
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
ir Sunderlal Hospital Institute Of Medical Science Banaras Hindu University Varanasi 221005 Uttar Pradesh India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kalpana Patni |
Sir Sunder Lal Hospital Banaras Hindu University Varanasi |
Room No. 25 Department Of kaumarbhritya/Balroga Faculty OF Ayurveda, IMS BHU
Institute of Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH |
9456140578
kalpana.patni@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Medical Science ,Banaras Hindu University , Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F948||Other childhood disorders of social functioning. Ayurveda Condition: Unmad, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Swarnaprashan, Reference: Kashyap Samhita Sutra Sthāna 18.26–27, Route: Oral, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Madhu- Ghrita), Additional Information: Shirodhara |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 3 to 10 years satisfying M CHART Scale criteria.
Patient diagnosed as autism irrespective of sex, religion, etc. will be included in the
study. |
|
| ExclusionCriteria |
| Details |
Children with physical disability
18
• Children with psychiatric illness.
• Children with gross brain damage causing mental retardation.
• Children with any genetic disorder
• Unreliable history. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
CBC
ESR
Syrum IgG
IQ Test
Anthropometry |
Before intervention
Then after 60th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in criteria in the scale for
State of appetite
Recurrent Fever
Recurrent URTI
Recurrent LRTI
Recurrent Loose stool
Recurrent abdominal pain
Recurrent Skin infection
Fatigue
Sleeping pattern
Difficulty to concentrate in memory |
Follow up on
30th day
60th day
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2025 |
| 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
|
In Ayurveda, the condition Autism may be understood on the lines of Unmad in a lesser degree and can be categorized as a minor psychological ailment of the child. Unmad is a clinical condition characterized by indecisiveness (Dhee Vibram) and unstable mind (Satwapariplawa), looking elsewhere usually by avoiding eye contact (Paryakuladrishti), lack of courage (Adheerata) incoherent and indistinct talk. (Abaddha Avaya) and lack of insight or imagination due to inability to process sensory information (Hridayamcha Shoonyam), when these symptoms exist in a minor form it could be considered as autistic behaviour.
SUVARNAPRASANA - Administration of colloidal gold using fine particles of metallic gold or suvarna bhasma has been advised in Ayurveda in infants and children in various forms. Suvarnaprashana described in Kashyapa Samhita is intended to boost memory, intelligence and immunity in infants. It is one of the oldest applications of gold nano medicine. Suvarnaprashana therapy is becoming widely popular and being administered on the Pushya nakshatra of every month at Ayurveda centers across India. Clinical and pharmacological studies show immunomodulatory, no tropic as well as therapeutic effects of Suvarnaprashana therapy |