| CTRI Number |
CTRI/2023/11/060280 [Registered on: 28/11/2023] Trial Registered Prospectively |
| Last Modified On: |
22/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effectiveness of Homoeopathic Medicines in the management of Autism. |
|
Scientific Title of Study
|
Effectiveness of Individualized Homoeopathic Medicines in LM Potencies in the management of children with Autism Spectrum Disorder |
| 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. Sourabh Balgonda Patil |
| Designation |
Post Graduate Scholar, Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram (P.O),
Kurichy
Kottayam
KERALA
686532
India |
| Phone |
8793250652 |
| Fax |
|
| Email |
iamsourabh.patil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. R. Bhuvaneswari |
| Designation |
Professor and Head of the Department, Research Officer (H), Scientist III, Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram (P.O),
Kurichy
Kottayam
KERALA
686532
India |
| Phone |
8281475541 |
| Fax |
|
| Email |
dr.r.bhuvaneswari2021@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. R. Bhuvaneswari |
| Designation |
Professor and Head of the Department, Research Officer (H), Scientist III, Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram (P.O),
Kurichy
Kottayam
KERALA
686532
India |
| Phone |
8281475541 |
| Fax |
|
| Email |
dr.r.bhuvaneswari2021@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health, Kottayam |
|
|
Primary Sponsor
|
| Name |
Dr Sourabh Balgonda Patil |
| Address |
National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram (P.O),
Kurichy
Kottayam,
Kerala 686532,
India |
| 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 Sourabh Balgonda Patil |
National Homoeopathy Research Institute in Mental Health |
OPD, IPD, Camps and Peripheral Units,
Department of Psychiatry,
National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram (P.O),
Kurichy
Kottayam
KERALA |
8793250652
iamsourabh.patil@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, Kottayam |
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 Medicines in LM Potencies |
Appropriate Individualized Homoeopathic Medicine will be started from the 0/1 or the
least available LM potency; followed by the next higher potency, serially, as per need of the
case. The pharmacist on instruction from the investigator will dispense the medicine/placebo as
follows: One globule (poppy seed size) of the desired potency will be dissolved in 120 ml of
distilled water, containing 2.4 ml (2% v/v) of dispensing alcohol, premixed in it, followed by 10
uniformly forceful downward strokes will be given against the bottom of the phial. The medicine
would be repeated as per the instructions given in the literature. Each participant will be advised
to give 10 uniformly forceful downward strokes to the bottle with the hand on a hard surface and
to take three teaspoonfuls (15 ml) of this solution and mix it in eight teaspoonfuls (40 ml) of
water in a clean glass after stirring the solution for each dose of medicine would be taken. One
teaspoonful (5 ml) of this solution will constitute one dose. If no change at all the case shall be
retaken and another appropriate Individualized Homoeopathic remedy will be prescribed. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Children in the age group of 3 to 17 years and both sexes.
2. Participants diagnosed with Autism Spectrum Disorder as per the DSM–V. |
|
| ExclusionCriteria |
| Details |
1. Participants diagnosed with any organic disorders.
2. Participants with any other serious medical illness and multiple disabilities. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of reduction in the severity of symptoms in children with Autism Spectrum Disorder after the administration of Individualized Homoeopathic Medicines in LM potencies is planned to be done every month using the Indian Scale for Assessment of Autism (ISAA). |
Every month from baseline till the conclusion of the study (12th month) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The changes in the challenging behavior in children with Autism Spectrum Disorder after the administration of Individualized Homoeopathic Medicines in LM potencies will be assessed at baseline, at 3rd, 6th, 9th month and at the conclusion of the study by using the Aberrant Behavior Checklist (ABC) scale. |
Baseline, at 3rd, 6th, 9th month and at the conclusion of the study (12th month) |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
04/12/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study is an open label, single arm, clinical interventional study to determine the effectiveness of Individualized Homoeopathic Medicines in LM potencies in the management of children with Autism Spectrum Disorder that will be conducted in OPD, IPD and Peripheral units of Department of Psychiatry at National Homoeopathy Research Institute in Mental Health, Kottayam. The primary outcome measures will be, the reduction in the severity of symptoms; assessed using the Indian Scale for Assessment of Autism (ISAA) every monthly. The secondary outcome will be, the changes in the challenging behavior; assessed every three months by using the Aberrant Behavior Checklist (ABC) scale. As the study with the aforementioned domains is one of its kind, it aims to make the efforts to offer possibilities for future research in the effectiveness of Individualized Homoeopathic Medicines in LM potency in management of children with Autism Spectrum Disorder in general and in the management of challenging behaviors in particular. |