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CTRI Number  CTRI/2025/08/092179 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 29/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   A study to see how homeopathic medicines can help children with moderate Intellectual disability in improving their social maturity skills 
Scientific Title of Study   AN OPEN LABEL SINGLE ARM STUDY TO EVALUATE THE ROLE OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN ENHANCING SOCIAL MATURITY IN CHILDREN WITH MODERATE INTELLECTUAL DISABILITY 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shivani 
Designation  Post Graduate Resident 
Affiliation  Swasthya Kalyan Homoeopathic Medical College and Research Centre Jaipur 
Address  OPD Medicine 2 Room number 30 Psychiatry Department 10 A Institutional Area Tonk road Goner road Sitapura Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9017135913  
Fax    
Email  aryashivani2000@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swarupananda Sarkar 
Designation  Associate Professor 
Affiliation  Swasthya Kalyan Homoeopathic Medical College and Research Centre Jaipur 
Address  16 Dayanand Nagar Khudanpuri road Alwar Rajasthan
OPD Medicine 2 Room number 30 Psychiatry Department 10 A Institutional Area Tonk road Goner road Sitapura Jaipur
Alwar
RAJASTHAN
301001
India 
Phone  9414483643  
Fax    
Email  drsarkarhomoeopathy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Swarupananda Sarkar 
Designation  Associate Professor 
Affiliation  Swasthya Kalyan Homoeopathic Medical College and Research Centre Jaipur 
Address  16 Dayanand Nagar Khudanpuri road Alwar Rajasthan
OPD Medicine 2 Room number 30 Psychiatry Department 10 A Institutional Area Tonk road Goner road Sitapura Jaipur
Alwar
RAJASTHAN
301001
India 
Phone  9414483643  
Fax    
Email  drsarkarhomoeopathy@gmail.com  
 
Source of Monetary or Material Support  
Swasthya Kalyan Homoeopathic Medical College and Research Centre, 10-A, Sitapura Institutional area, Tonk road, Goner road, Sitapura Industrial Area, Jaipur, Rajasthan, 302022 
 
Primary Sponsor  
Name  Swasthya Kalyan Homoeopathic Medical College and Research Centre 
Address  Swasthya Kalyan Homoeopathic Medical College and Research Centre, 10-A, Sitapura Institutional area, Tonk road, Goner road, Sitapura Industrial Area, Jaipur, Rajasthan, 302022 
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 Swarupananda Sarkar  Swasthya Kalyan Homoeopathic Medical College and Research Centre  OPD Medicine 2 Room number 30 Psychiatry Department 10 A Institutional area Tonk road Goner road Sitapura Jaipur Rajasthan
Jaipur
RAJASTHAN 		 9414483643

drsarkarhomoeopathy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SKHMCIEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F71||Moderate intellectual disabilities,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic medicines  4 pills/HS, Pills number 40, Route of drug administration- Sublingual, Doses and frequency will be according to the susceptibility of patient 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Diagnosed cases of Intellectual disability
 
 
ExclusionCriteria 
Details  1. Children with acute or chronic neurological disorders
2. Children with genetic syndromes
3. Children with advanced pathological illness
4. Children with significant sensory impairments
5. Children having Autism spectrum disorder with Intellectual disability 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the changes in social maturity after homoeopathic medicines in the children with moderate intellectual disability.  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   29/08/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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   This study is an open label single arm study to evaluate the role of individualized homoeopathic medicines in enhancing social maturity in children with moderate intellectual disability. This study will be conducted at Swasthya Kalyan Homoeopathic Medical College and Research Centre, Jaipur. The sample size for this study is estimated to be 38. The primary outcome measures will be social score assessment, social quotient assessment, regular follow up assessment. It will be conducted for 1 year. The objectives are to assess the changes in social maturity after homoeopathic medicines in the children with moderate intellectual disability. 
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