| CTRI Number |
CTRI/2025/10/095604 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To test how Effective Homoeopathic Medicines are in the Treatment of Underweight School going Children |
|
Scientific Title of Study
|
EFFECTIVENESS OF HOMOEOPATHIC TREATMENT IN CASES OF UNDERWEIGHT (IAP GRADE I AND II OF PEM) SCHOOL GOING CHILDREN AGED 6-12 YEARS - A SINGLE-BLIND RANDOMIZED CONTROL 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 Sonali Mandal |
| Designation |
PhD Scholar |
| Affiliation |
Adarsh Shikshan Sansthas Sonajirao Kshirsagar Homoeopathic Medical College |
| Address |
Department of Paediatrics Room no 14 1st floor Department of Post Graduate Block
Adarsh Shikshan Sansthas Sonajirao Kshirsagar
Homoeopathic Medical College
Vidhya Nagar (W)
College Road (W)
Beed
Bid
MAHARASHTRA
431122
India |
| Phone |
9833180915 |
| Fax |
|
| Email |
sonali.sonigoldfinch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahadev Dagduba Age |
| Designation |
Professor, HOD Department of Paediatrics |
| Affiliation |
Adarsh Shikshan Sansthas, Sonajirao Kshirsagar Homoeopathic Medical College |
| Address |
Department of Paediatrics Room no 14 1st floor Department of Post Graduate Block
Adarsh Shikshan Sansthas Sonajirao Kshirsagar
Homoeopathic Medical College
Vidhya Nagar (W)
College Road (W)
Beed
Bid
MAHARASHTRA
431 122
India |
| Phone |
9422744892 |
| Fax |
|
| Email |
draagemd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahadev Dagduba Age |
| Designation |
Professor, HOD Department of Paediatrics |
| Affiliation |
Adarsh Shikshan Sansthas, Sonajirao Kshirsagar Homoeopathic Medical College |
| Address |
Department of Paediatrics Room no 14 1st floor Department of Post Graduate Block
Adarsh Shikshan Sansthas Sonajirao Kshirsagar
Homoeopathic Medical College
Vidhya Nagar (W)
College Road (W)
Beed
Bid
MAHARASHTRA
431 122
India |
| Phone |
9422744892 |
| Fax |
|
| Email |
draagemd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. M. L. Dhawale Memorial Homoeopathic Institute
Palghar Palghar Boisar Road, Opp. Municipal Corporation and Fire Brigade, Palghar 401 404, Dist. Palghar, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Sonali Mandal |
| Address |
Dr. M. L. Dhawale Memorial Homoeopathic Institute, Palghar Boisar Road, Opp. Municipal Corporation and Fire Brigade, Palghar 401 404, Dist. Palghar, Maharashtra, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Adarsh Shikshan Sansthas Sonajirao Kshirsagar Homoeopathic Medical College |
Adarsh Shikshan Sansthas, Sonajirao Kshirsagar
Homoeopathic Medical College,
Vidhya Nagar (W) , College Road (W),
Beed-431 122 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonali Mandal |
Adarsh Shikshan Sansthas, Sonajirao Kshirsagar Homoeopathic Medical College |
Vidhya Nagar (W), College Road (W),
Beed 431 122
Bid
MAHARASHTRA |
9833180915
sonali.sonigoldfinch@gmail.com |
| Dr Sonali Mandal |
Dr M L Dhawale Memorial Homoeopathic Institute, Palghar |
Palghar Boisar Road,
Opp. Municipal Corporation and Fire Brigade,
Palghar 401 404,
Dist. Palghar,
Maharashtra,
India
Palghar
MAHARASHTRA |
9833180915
sonali.sonigoldfinch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Adarsh Shikshan Sansthas, Sonajirao Kshirsagar Homoeopathic Medical College, Institutional ethical commitee |
Approved |
| Adarsh Shikshan Sansthas, Sonajirao Kshirsagar Homoeopathic Medical College, Institutional ethical commitee |
Approved |
| Adarsh Shikshan Sansthas, Sonajirao Kshirsagar Homoeopathic Medical College, Institutional ethical commitee |
Approved |
| Dr M L Dhawale Memorial Homoeopathic Institute, Institutional Ethical Commitee |
Approved |
| MUHS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E441||Mild protein-calorie malnutrition, (2) ICD-10 Condition: E440||Moderate protein-calorie malnutrition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indicated Homoeopathic
Medicine |
Group 1- Homoeopathic Treatment Group- They will be prescribed Indicated Homoeopathic
Medicine and Standard Nutritional Care. Indicated Homoeopathic Medicine will be given in
pills size 30 in ½ dram bottles or 1 dram bottle in coded form for 1 month along with Standard
Nutritional Care |
| Comparator Agent |
Placebo |
Group 2- Control group- They will be prescribed Placebo and Standard Nutritional Care.
Placebo will be given in pills size 30 in ½ dram bottles or 1 dram bottle in coded form for 1
month along with Standard Nutritional Care |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Underweight (IAP Grade I and II PEM) school-going children.
Diagnosed cases of Grade I and II PEM with weight for age calculated according to IAP
guidelines.
Parental assent obtained for their inclusion in this study. |
|
| ExclusionCriteria |
| Details |
Children with only stunting will not be included in this study.
Cases of severe concomitant diseases (including severe renal, cardiac, hepatic, and/or
immunosuppressive diseases), and cancer.
Participation in another clinical study during the 6 months before study enrolment or Previous or
current use of homeopathic treatments for undernutrition |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To measure changes in the weight-for-age over a 12-month period in underweight (IAP Grade I
and II PEM) school-going children aged 6-12 years receiving homeopathic treatment and
standard nutritional care (homeopathic treatment group) and those receiving only standard
nutritional care (control group).
2. To compare the weight for age outcomes in underweight (IAP Grade I and II PEM) school-going
children aged 6-12 years in the homeopathic treatment group with the control group after a 12
month period. |
Weight for age of all the study subjects will be plotted on the IAP (5-18 years – Boys and Girls)
and WHO (5-19years – Boys and girls) growth charts at the beginning of Intervention in both the
groups and monthly during Follow –up assessment for a period of 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To document the specific homeopathic remedies that show significant effectiveness in treatment
of underweight (IAP Grade I and II PEM) school going children aged 6-12 years.
2. To document any notable differences in the effectiveness of homeopathic treatments between
underweight (IAP Grade I and II PEM) school going boys and girls aged 6-12 years. |
Weight for age of all the study subjects will be plotted on the IAP (5-18 years – Boys and Girls)
and WHO (5-19years – Boys and girls) growth charts at the beginning of Intervention in both the
groups and monthly during Follow –up assessment for a period of 12 months |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
11/12/2025 |
| 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="0"
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
|
In spite of these ongoing nutrition initiatives, Malnutrition amongst school going children is still evident as seen in various literature reviews as stated above. Indicated Homoeopathic medicine has been helpful in treating cases of malnutrition in underweight children which has been a positive past clinical experience in children below 5 years of age. But a proper Homoeopathic research study project with a rationale and specific study objective is needed to prove the effectiveness of Homoeopathic Treatment in cases of underweight (IAP grade I and II of PEM) school going children. Thus this Single Blind Randomized Trial aims to evaluate the effectiveness of homeopathic treatment in improving the weight for age in underweight school-going children aged 6-12 years with IAP Grade I and II Protein-Energy Malnutrition (PEM). |