| CTRI Number |
CTRI/2025/02/080947 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of homoeopathic medicines in the treatment of undernutrition |
|
Scientific Title of Study
|
Role of individualized homoeopathic medicines in the management of undernutrition assessed by who growth charts (z-score) in 3 to 5 year aganwadi children-a randomised single-blind controlled 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 PAYAL DASHRATHBHAI SHRIMALI |
| Designation |
PG SCHOLAR |
| Affiliation |
SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF PAEDIATRIC ROOM NO 5 GROUND FLOOR SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA
Mahesana
GUJARAT
384001
India |
| Phone |
9426033591 |
| Fax |
|
| Email |
payalshrimali00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RAHUL SUTARIYA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF HOMOEOPATHIC MATERIA MEDICA ROOM NO 15 GROUND FLOOR SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA
Mahesana
GUJARAT
384001
India |
| Phone |
8140415881 |
| Fax |
|
| Email |
dr.rvsutariya02@gamil.com |
|
Details of Contact Person
Public Query
|
| Name |
DR PAYAL DASHRATHBHAI SHRIMALI |
| Designation |
PG SCHOLAR |
| Affiliation |
SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF PAEDIATRIC ROOM NO 5 GROUND FLOOR SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA
Mahesana
GUJARAT
384001
India |
| Phone |
9426033591 |
| Fax |
|
| Email |
payalshrimali00@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA GUJARAT 384001
|
|
|
Primary Sponsor
|
| Name |
DR PAYAL DASHRATHBHAI SHRIMALI |
| Address |
DEPARTMENT OF PAEDIATRIC ROOM NO 5 GROUND FLOOR SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA |
| 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 PAYAL DASHRATHBHAI SHRIMALI |
SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLAGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA GUJARAT 384001
Mahesana
GUJARAT |
09426033591
payalshrimali00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Smt A J Savla Homoeopathic Medical College and Research Institute Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E639||Nutritional deficiency, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines |
Potency various Dose as per need of case frequency as per need of case route of administration oral duration of 8 months as per need of case |
| Comparator Agent |
Placebo |
Frequency as per need of case route of administration oral duration of 8 months as per need of case |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
Anganwadi children of Mehsana City of Mehsana district 3 to 5 years of age |
|
| ExclusionCriteria |
| Details |
Children with congenital anomalies eg heart defects such as missing or misshaped valves down syndrome neural tube defects Children with pre existing diseases eg Sickle cell disease hemophilia cerebral palsy cystic fibrosis diabetes epilepsy Autism PEM below minus 3 sd according to z score |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the WHO Growth Chart in undernutrition child |
Will be Calculated Every Month treatment of 8 months of duration |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/02/2025 |
| Date of Study Completion (India) |
17/10/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
17/10/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 RCT study ANOVA test with two groups placebo and Homoeopathic medicines, an experimental study of the role of Homoeopathic medicines for 8 months in 40 participants with undernutrition in 3 to 5 year children that will be conducted as per inclusion and exclusion criteria from Anganwadi and outcome measures will assess increase in who growth chart and participate follow up every month up to 8 month |