| 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
|
|
|
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
|
|
|
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. |