| CTRI Number |
CTRI/2025/09/094991 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
14/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of homoeopathic medicine and Bach flower medicine for treatment of autism in children. |
|
Scientific Title of Study
|
Management of Autism spectrum disorder in children with individualized homoeopathic remedy versus individualized homoeopathic remedy with Bach flower remedy as an adjuvant :A prospective single blind clinical trial. |
| 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 Deepalika Sharma |
| Designation |
PG SCHOLAR |
| Affiliation |
BVDUHMC - PUNE |
| Address |
Bharati Vidyapeeth (Deemed To Be University)Homoeopathic Medical College And Hospital Department Of Postgraduate And Research Centre Satara Road Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7974899905 |
| Fax |
|
| Email |
deepalika.sharma-hmcpune@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati R Shinde |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed To Be University)Homoeopathic Medical CollegeAnd Hospital Pune |
| Address |
Bharati Vidyapeeth (Deemed To Be University)Homoeopathic Medical College And Hospital ,Department Of Postgraduate And Research Centre Satara Road - Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9890140393 |
| Fax |
|
| Email |
swati.shinde@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati R Shinde |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth (Deemed To Be University)Homoeopathic Medical CollegeAnd Hospital Pune |
| Address |
Bharati Vidyapeeth (Deemed To Be University)Homoeopathic Medical College And Hospital ,Department Of Postgraduate And Research Centre Satara Road - Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9890140393 |
| Fax |
|
| Email |
swati.shinde@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Deepalika Sharma |
| Address |
Bharati Vidyapeeth (Deemed To Be University)Homoeopathic Medical College And Hospital Department Of Postgraduate And Research Centre Satara Road Pune |
| 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 Deepalika Sharma |
BVDUHMCH |
Bharati Vidyapeeth (Deemed To Be University)Homoeopathic Medical College And Hospital ,Department Of Postgraduate And Research Centre Dhankawadi ,Satara Road - Pune
Pune
MAHARASHTRA |
07974899905
deepalika.sharma-hmcpune@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed To Be University)Homoeopathic Medical College And Hospital Department Of Postgraduate And Research Centre Satara Road Pune |
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 Remedy |
Patient will be treated with individualized homoeopathic remedy which will be selected on the basis of totality of symptom with particular focus on physical mental emotional and behavioral characteristics .Medicine will be administered orally in globule form .Doses and repetition will be depend on cases requirement .follow-up in every 15 days with INDIAN SCALE OF AUTISM ASSESSTMENT (ISAA) for 6 month. |
| Comparator Agent |
Individualized homoeopathic remedy with Bach flower remedy as an adjuvant |
Patient will be treated with individualized homoeopathic remedy with Bach flower remedy as an adjuvant . Bach flower remedy will be selected on emotional and behavioral symptoms along with individualized homoeopathic remedy on basis totality of symptoms . Both the medicine will be administrated orally in globule form. doses and repetition will be depend on cases required .Follow-up in every 15 days with ISAA scale for 6 month . |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Children age 5-12 years .
2.Patient of both the sexes male and female
3.Mild and moderate autism according to ISAA scale 4.Parent able to provide written informed accent .
|
|
| ExclusionCriteria |
| Details |
1.Severe autism according to ISAA scale.
2. Presence of other neurological disorder.
3.Participation in other clinical trials in past 3 month.
4.Patient age of below 5 year and above 12 years. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in behavioral, cognitive and emotional symptoms in children with ASD, measured using the ISAA pre, mid, and post stage . |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement in quality of life in children with ASD.
2.Effectiveness of Bach Flower Remedy as an adjuvant to individualized homoeopathic remedy . |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
25/09/2025 |
| 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="3"
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
|
A prospective, single-blind, computerized randomized clinical trial to compare the effectiveness of individualized homoeopathic remedy alone versus individualized homoeopathic remedy with Bach Flower Remedies (BFRs) as an adjuvant in the management of Autism Spectrum Disorder (ASD) in children of aged 5–12 years group . A total of 30 pre-diagnosed cases of mild to moderate ASD will be enrolled and random allocated into two parallel groups each group will have 15 participants : Group A: Individualized homoeopathic remedy Group B: Individualized homoeopathic remedy with Bach flower remedies (BFRs) as adjuvant The intervention will be administered for 6 months, with follow-up over 6 months. Outcomes will be assessed using the Indian Scale for Assessment of Autism (ISAA) at baseline, mid-point, and post-treatment. Primary outcome: Improvement in behavioral, cognitive, and emotional symptoms in ASD children.
Secondary outcomes: Improvement in quality of life and documentation of the effectiveness of Bach flower remedies BFRs as an adjuvant to individualized homoeopathic remedy . Statistical analysis will be performed using the Independent T-test to compare differences between groups. |