FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/090410 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 10/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   Exploring if homoeopathy can bring changes in coping mechanisms of parents of autism spectrum disorder children 
Scientific Title of Study   Exploring the changes in the coping mechanisms assessed by Brief Coping Orientation to Problems Experienced (COPE) Inventory after Homoeopathic Intervention in Parents of Autism Spectrum Disorder: An Experimental uncontrolled 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 Safah Shaikh 
Designation  Student 
Affiliation  DR M L DHAWALE MEMORIAL HOMOEOPATHIC INSTITUTE 
Address  301, 3rd FLOOR, DEPARTMENT OF PSYCHIATRY,DR M L DHAWALE MEMORIAL HOMOEOPATHIC INSTITUTE, PALGHAR BOISAR ROAD,OPP S.T. WORKSHOP,DIST PALGHAR.

Thane
MAHARASHTRA
401404
India 
Phone  8779558065  
Fax    
Email  safahshaikh21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunita Nikumbh 
Designation  Head Of Department 
Affiliation  DR M L DHAWALE MEMORIAL HOMOEOPATHIC INSTITUTE 
Address  301, 3rd FLOOR, DEPARTMENT OF PSYCHIATRY,DR M L DHAWALE MEMORIAL HOMOEOPATHIC INSTITUTE, PALGHAR BOISAR ROAD,OPP S.T. WORKSHOP,DIST PALGHAR.

Thane
MAHARASHTRA
401404
India 
Phone  7721076363  
Fax    
Email  sunita.nikumbh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Safah Shaikh 
Designation  Student 
Affiliation  DR M L DHAWALE MEMORIAL HOMOEOPATHIC INSTITUTE 
Address  301, 3rd FLOOR, DEPARTMENT OF PSYCHIATRY,DR M L DHAWALE MEMORIAL HOMOEOPATHIC INSTITUTE, PALGHAR BOISAR ROAD,OPP S.T. WORKSHOP,DIST PALGHAR.

Thane
MAHARASHTRA
401404
India 
Phone  8779558065  
Fax    
Email  safahshaikh21@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  DR M L DHAWALE MEMORIAL HOMOEOPATHIC INSTITUTE 
Address  DR M L DHAWALE MEMORIAL HOMOEOPATHIC INSTITUTE, PALGHAR BOISAR ROAD,OPP S.T. WORKSHOP,DIST PALGHAR. 
Type of Sponsor  Private medical college 
 
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 Safah Shaikh  DR M L DHAWALE HOMOEOPATHIC INSTITUTE, PALGHAR  301, 3rd FLOOR, DEPARTMENT OF PSYCHIATRY,DR M L DHAWALE MEMORIAL HOMOEOPATHIC INSTITUTE, PALGHAR BOISAR ROAD,OPP S.T. WORKSHOP,DIST PALGHAR.
Thane
MAHARASHTRA 		 08779558065

safahshaikh21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR M L DHAWALE  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  Indicated Homoeopathic Medicine  Indicated Homoeopathic Medicine, dose given according to susceptibility of patient, oral route of administration, frequency- OD. Duration of intervention will be 6 months. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  - Either one of the parent or both the parents.
- Parents of ASD child having at least one chronic miasmatic illness. Parents having lifestyle diseases and non-communicable disease.
- Parents with illnesses precipitating or aggravating after the diagnosis of the child.
- Psychiatric illnesses of neurotic nature.
 
 
ExclusionCriteria 
Details  - Parents with psychotic illnesses. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Exploring the change in the coping mechanisms assessed by Brief COPE Inventory after Homoeopathic Intervention in parents of Autism Spectrum Disorder .  6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   25/07/2025 
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="0"
Months="6"
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   This research aims at exploring the changes in the coping mechanism as assessed by the brief cope orientation to problems experienced (COPE) inventory after homeopathic intervention in parents of autism spectrum disorder. This is an experimental uncontrolled study. The involvement of parents in supporting and treating children with autism is vital, particularly considering the challenges they face in behavior, communication, and social interaction. Parents facilitate significant developmental and educational opportunities for these children, and they play a central role in the child’s growth; and any alteration to this would be inappropriate for the child. Their primary objective is to contribute to the optimal development of the child within a secure environment. As a result, parents of children with disabilities frequently endure more physical symptoms, negative emotions, and reduced psychological well-being compared to parents who do not have a child with disabilities. Having healthy coping mechanisms is crucial for parents of autistic children because it allows them to manage stress, maintain their well-being, and provide better support to their child. It helps them stay resilient in the face of challenges. Overall, healthy coping mechanism empowers parents to navigate through the complexities of raising a child with autism with resilience, compassion, and strength. The efficacy of homeopathic treatment on caregivers or parents of autistic children remains largely unexplored within formal research settings. Despite the absence of comprehensive studies, there exists significant potential to delve into this area. Understanding how homeopathic remedies may impact the well-being, stress levels, and overall quality of life of parents could offer valuable insights for parents as well as children. The primary objective of this research is to explore the scope of homeopathic intervention on alteration of coping mechanisms in parents of autistic children as assessed by brief scope inventory. 
Close