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CTRI Number  CTRI/2024/07/070980 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 19/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Evaluating homeopathic treatments for sleep problems in children with Autism using a Sleep Habits Questionnaire. 
Scientific Title of Study   Assessing the efficacy of individualized homeopathic intervention in alleviating sleep dysregulation in children with Autism Spectrum Disorder: An experimental study utilizing CSHQ (Childrens Sleep Habits Questionnaire) 
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 Shraddha Shendre 
Designation  Associate Professor 
Affiliation  Smt Malini Kishore Sanghvi Homoeopathic Medical College & Hospital 
Address  Room No 16 Dept of Community Medicine Smt Malini Kishore Sanghvi Homoeopathic Medical College and Hospital Campus opp Sumeru Tirth Karjan amod road

Vadodara
GUJARAT
391240
India 
Phone  9716413556  
Fax    
Email  shraddha.shendre4@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Hema Parikh 
Designation  Professor and HOD 
Affiliation  Smt Malini Kishore Sanghvi Homoeopathic Medical College and Hospital 
Address  Department of Repertory Smt malini kishore sanghvi homoeopathic medical college and hospital opposite sumeru tirth,Karjan Amod road, Karjan district Vadodara

Vadodara
GUJARAT
391240
India 
Phone  09825944977  
Fax    
Email  dr.hmparikh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shraddha Shendre 
Designation  Associate Professor 
Affiliation  Smt Malini Kishore Sanghvi Homoeopathic Medical College and Hospital 
Address  Room No 16 Dept of Community Medicine Smt Malini Kishore Sanghvi Homoeopathic Medical College and Hospital Campus opp Sumeru Tirth Karjan amod road Karjan

Vadodara
GUJARAT
391240
India 
Phone  9716413556  
Fax    
Email  shraddha.shendre4@gmail.com  
 
Source of Monetary or Material Support  
Smt. Malini Kishore Sanghvi Homoeopathic Medical College and Hospital opposite Sumeru tirth, karjan amod road, Karjan, district Vadodara Gujrat India, Pincode 391240 
 
Primary Sponsor  
Name  DrShraddha Shendre 
Address  Room no 16 Dept of Community Medicine Smt Malini Kishore Sanghvi Homoeopathic Medical College and Hospital, opposite Sumeru tirth, karjan-amod road, Karjan, district Vadodara, Gujarat, India Pincoe 391240 
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 Shraddha Shendre  Smt malini kishore sanghvi homoeopathic medical college and hospital  Department of paediatric, Centre for Autism, OPD no-17
Vadodara
GUJARAT 
9716413556

shraddha.shendre4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Smt Malini Kishore Sanghvi Homoeopathic Medical College and Hospital Institutional Ethical Committee  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  Individualized Homoeopathic Intervention  Dose- 3 pills of 30C, 200C, 1M, 10M, 0/1 Frequency- Weekly one dose Route of administration- oral Intervention duration- 3 months along with psychotherapy 
Comparator Agent  Placebo- R2 Pills  Dose- 3 pills of Placebo Frequency- Weekly one dose Route of administration- oral Intervention duration- 3 months along with psychotherapy 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  1. Diagnosed case of Autism Spectrum Disorder as confirmed by a
qualified professional.
2. Sleep dysregulation, including difficulties with sleep onset, night
awakenings, or overall poor sleep quality.
3. Age between 3 and 15 years  
 
ExclusionCriteria 
Details  1.Have significant medical conditions, gross pathological
comorbidity, or sleep disorders unrelated to their ASD diagnosis
(e.g. Obstructive sleep apnoea, chronic kidney or lung disease,
obesity, Diabetes, Hypothyroidism, hereditary tendency of sleep
dysregulation etc.)
2.Are currently receiving any other alternative or complementary
treatments for ASD or sleep difficulties (e.g.- Melatonin 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Efficacy of individualized homeopathic intervention in alleviating sleep dysregulation in children diagnosed with Autism Spectrum Disorder (ASD).  Post intervention assessment after 3 months through CSHQ
 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in sleep pattern and parameters  Measured at baseline and at end of the 3 months intervention period through CSHQ 
Improvement in Symptoms of ASD  Measured at baseline and at end of the 3 month intervention period through Autism Treatment Evaluation Checklist 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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/ Phase 3 
Date of First Enrollment (India)   30/07/2024 
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="3"
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  
Title: Assessing the Efficacy of Individualized Homeopathic Intervention in Alleviating Sleep Dysregulation in Children with Autism Spectrum Disorder: An Experimental Study Utilizing CSHQ (Children’s Sleep Habits Questionnaire)
Introduction: Sleep dysregulation is a prevalent issue among children with autism spectrum disorder (ASD), affecting up to 80% of this population. These disturbances significantly impact the child’s well-being and family dynamics. Traditional medical treatments have limitations, prompting exploration of alternative therapies such as individualized homeopathic interventions.

Primary Objective: To determine the effectiveness of individualized homeopathic intervention in alleviating sleep dysregulation in children with ASD, as measured by the Children’s Sleep Habits Questionnaire (CSHQ).
Secondary Objectives:
1. To compare changes in sleep patterns and parameters (e.g., sleep onset latency, sleep duration, night awakenings) between the experimental group receiving homeopathic intervention and the control group not receiving the intervention.
2. To evaluate the association between the improvement of sleep dysregulation and the reduction in ASD symptoms.

Methodology:
- Study Type: Experimental Study
- Study Design: Randomized Controlled Trial (RCT), Double Blinded
- Participants: 50 children aged 3-15 years with ASD and sleep dysregulation, divided into an experimental group (30 participants) and a control group (20 participants).
- Intervention: The experimental group will receive individualized homeopathic treatment, while the control group will receive a placebo. Both groups will also receive psychotherapy.
- Duration: The intervention period will last for 3 months.
- Measurements: Sleep patterns will be assessed using the CSHQ at baseline and post-intervention. ASD symptoms will be evaluated using standardized diagnostic criteria.

Expected Outcomes: The study aims to provide evidence on the efficacy of homeopathic interventions in improving sleep and reducing ASD symptoms, offering a potential non-pharmacological treatment option.

Ethical Considerations: The study will adhere to ethical guidelines, ensuring informed consent, privacy, and confidentiality of participants. Ethical approval will be obtained from relevant institutional review boards.

Conclusion: This study seeks to enhance understanding of homeopathic interventions as a viable treatment for sleep dysregulation in children with ASD, potentially improving their overall quality of life and that of their families.
 
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