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CTRI Number  CTRI/2025/06/089335 [Registered on: 23/06/2025] Trial Registered Prospectively
Last Modified On: 23/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Improvement of restricted and repetitive behaviour in autism spectrum disorder in LM potency 
Scientific Title of Study   Effectiveness of Individualised Homoeopathic medicine in LM potency in restricted and repetitive behaviour of autism spectrum disorder-A Quasi experimental study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr BREETHNI M 
Designation  PG scholar , Dept of psychiatry 
Affiliation  National Homeopathy Research Institute in Mental Health Kottayam 
Address  Department of psychiatry, PG scholar,room no:8 National Homoeopathy Research Institute in Mental Health

Kottayam
KERALA
686532
India 
Phone  7708598373  
Fax    
Email  breethni.tm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr JAYASHREE JANAGAM 
Designation  Assistant Professor, Department of Psychiatry 
Affiliation  National Homeopathy Research Institute in Mental Health Kottayam 
Address  Department of psychiatry, assistant professor,room no:6 National Homoeopathy Research Institute in Mental Health Sachivothamapuram p.o Kurichy Kottayam kerala 686532

Kottayam
KERALA
686532
India 
Phone  9177709429  
Fax    
Email  drjayajanagam@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr JAYASHREE JANAGAM 
Designation  Assistant Professor, Department of Psychiatry 
Affiliation  National Homeopathy Research Institute in Mental Health Kottayam 
Address  Department of psychiatry Assistant professor,room no:6National Homoeopathy Research Institute in Mental Health Sachivothamapuram p.o Kurichy Kottayam kerala 686532

Kottayam
KERALA
686532
India 
Phone  9177709429  
Fax    
Email  drjayajanagam@gmail.com  
 
Source of Monetary or Material Support  
National Homoeopathy Research Institute in Mental Health SACHIVOTHAMAPURAM KURICHY PO kottayam -686532 
 
Primary Sponsor  
Name  Dr. Breethni. M 
Address  National Homoeopathy Research Institute in Mental Health, Sachivothamapuram p.o, Kurichy , Kottayam-686532 
Type of Sponsor  Other [self] 
 
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 BREETHNIM  NATIONAL HOMOEOPATHY RESEARCH INSTITUTE IN MENTAL HEALTH  OPD, IPD and CAMPS OF NATIONAL HOMOEOPATHY RESEARCH INSTITUTE IN MENTAL HEALTH SACHIVOTHAMAPURAM po KURICHY KOTTAYAM KERALA 686532
Kottayam
KERALA 		 7708598373

breethni.tm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee-National Homoeopathy Research Institute in Mental Health  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualised Homoeopathic medicines in LM Potency   After enrollment the case will be repertorised. Appropriate potentized Individualised Homoeopathic Medicine will be administered in LM Potency in minimum dose in appropriate potency according to the need of the case. Medicine is administered orally. Repetition will be done when improvement comes to a standstill in a higher potency of the same medicine and if the medicine is not found to be effective the case will be retaken then another appropriate medicine is given. The above homoeopathic intervention will be given for a period of 1 year. 
Comparator Agent  Not applicable   Not applicable  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1.Autism spectrum disorder as per ICD-11 criteria.
2.Participants must be children aged between 3-18 years.
3.Children of both sexes.
4.RBQ-2 scoring greater or equal to 20 
 
ExclusionCriteria 
Details  Children suffering from other major psychiatric condition like Rett’s Syndrome, Asperger’
syndrome and stereotyped movement disorder 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of reduction in restricted and repetitive behaviour after administration of individualised Homoeopathic medicine in LM potency using Repetitive Behaviour Questionnaire-2  Every 3 months from baseline till conclusion of the study 
 
Secondary Outcome  
Outcome  TimePoints 
1. Determine which type of restricted and repetitive behaviour improved after
administration of Homoeopathic medicines in LM potency using Repetitive Behaviour
Questionnaire -2
2.Find out the global improvement of autism spectrum disorder with individualised
Homoeopathic medicines in LM potency using Indian Scale for Assessment of Autism. 		 Every 3 months from baseline till conclusion of study 
 
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   Phase 2 
Date of First Enrollment (India)   04/07/2025 
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="8"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [breethni.tm@gmail.com].

  6. For how long will this data be available start date provided 26-06-2025 and end date provided 11-11-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary   This quasi experimental study evaluates the effectiveness of individualised Homoeopathic medicine in  LM potency in restricted and repetitive behaviour in autism spectrum disorder using repetitive behaviour questionnaire-2(RBQ-2). Secondary objectives include which type of restricted and repetitive behaviour  improved after administration of Homoeopathic medicines in LM potency using Repetitive Behaviour Questionnaire -2 and assessing global improvement of autism using Indian scale for assessment of  autism(ISAA). Patients will be recruited from the Outpatient Department (OPD), Inpatient Department (IPD), and camps of the National Homoeopathy Research Institute in Mental Health  (NHRIMH), Kottayam, following screening based on ICD-11 criteria. Enrollment requires psychiatrist  confirmation, and informed consent will be obtained in English and Malayalam. Baseline assessments include RBQ-2 for restricted and repetitive behaviour and ISAA for global improvement of autism tri-monthly. A detailed case history and mental status examination will be recorded, and individualized homoeopathic remedies will be prescribed based on repertorization via RADAR OPUS software and Homoeopathic Materia Medica. Acute exacerbations will be managed accordingly. The study will track changes in restricted and repetitive behaviour in autism spectrum disorder using LM Potency.Patients missing follow-ups for three consecutive months will be considered dropouts and will receive standard
OPD care but will be excluded from further study evaluation. The study aims to find an improvement in reduction in  the Restricted and Repetitive behaviour in children with ASD after the administration of individualized Homeopathic medicine in LM potency. 
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