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CTRI Number  CTRI/2025/10/096425 [Registered on: 23/10/2025] Trial Registered Prospectively
Last Modified On: 22/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Effectiveness of Homoeopathic Medicines with Personalized Diet Plan in the Management of Malnutrition Among Children An Experimental Study 
Scientific Title of Study   Effectiveness of Individualized Homoeopathic Medicines in Management of Moderate Acute Malnutrition with Personalized Diet plan among children: An experimental non 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 Namrata Ingale 
Designation  PG Scholor 
Affiliation  Dr G D Pol Foundation YMT Homoeopathic Medical College PG Institute Hospital 
Address  Dr G D Pol Foundation YMT Homoeopathic Medical College PG Institute Hospital, First Floor, Pediatric Department, Room no.104 Institutional area Sector 4, Kharghar, Navi Mumbai 410210

Raigarh
MAHARASHTRA
410210
India 
Phone  9763676714  
Fax    
Email  namrataingale0000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prachi Utekar 
Designation  Associate Professor 
Affiliation  Dr G D Pol Foundation YMT Homoeopathic Medical College PG Institute Hospital 
Address  Dr G D Pol Foundation YMT Homoeopathic Medical College PG Institute Hospital, First Floor, Pediatric Department, Room no.104 Institutional area Sector 4, Kharghar, Navi Mumbai 410210

Raigarh
MAHARASHTRA
410210
India 
Phone  9594155421  
Fax    
Email  drprachiwagh@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Prachi Utekar 
Designation  Associate Professor 
Affiliation  Dr G D Pol Foundation YMT Homoeopathic Medical College PG Institute Hospital 
Address  Dr G D Pol Foundation YMT Homoeopathic Medical College PG Institute Hospital, First Floor, Pediatric Department, Room no.104 Institutional area Sector 4, Kharghar, Navi Mumbai 410210

Raigarh
MAHARASHTRA
410210
India 
Phone  9594155421  
Fax    
Email  drprachiwagh@yahoo.co.in  
 
Source of Monetary or Material Support  
Dr G D Pol Foundation YMT Homoeopathic Medical College PG Institute Hospital, First Floor, Pediatric Department, Room no.104 Institutional area Sector 4, Kharghar, Navi Mumbai 410210 
 
Primary Sponsor  
Name  Dr Namrata Ingale 
Address  Dr G D Pol foundation YMT Homoepathic Medical College Hospital and PG Institute Institutional Area Kharghar Sector 4 Navi Mumbai 410210 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Namrata Ingale  Dr G D Pol Foundation YMT Homoeopathic Medical College Hospital and PG Institute  Dr G D Pol Foundation YMT Homoeopathic Medical College PG Institute Hospital, First Floor, Pediatric Department, Room no.104 Institutional area Sector 4, Kharghar, Navi Mumbai 410210
Raigarh
MAHARASHTRA 
9763676714

namrataingale0000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
YMT Homoeopathic Medical College and PG Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E43||Unspecified severe protein-caloriemalnutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicines  To assess the patient Pre treatment and Post treatment for Homoeopathic Medicines based on process of Individualization. Dose of the medicine will be selected according to susceptibility of the patient that is 30C, 200C, 1M. Medicine will be given for a period of 4 months, with every 2 weeks follow up for each patient. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Clinically diagnosed cases of Moderate Acute Malnutrition according to WHO & IAP growth standards that is BMI For age less than Minus2SD OR Weight for Height Z scores between Minus2SD TO Minus3SD 
 
ExclusionCriteria 
Details  Suspected cases of Comgenital anamolies
Patients with Endocrine and Metabolic disorders such as GH Deficiency, Hypothyroidism, Juvenile Diabetes
Suspected cases of Malignancy
Immunocompromized patients 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Nutritional Status Improvement: The main outcome is improvement in nutritional status, measured by anthropometric indicators such as weight-for-height Z-scores.
2. Recovery from MAM: Recovery is defined as achieving normal weight-for-height Z-scores & BMI for age and sex, and a resolution of clinical signs of malnutrition (such as edema or visible wasting).
3. Regular follow ups will be taken every 2 weeks for 4 months to monitor nutritional status (Weight, Height, BMI)
 
From Baseline to Four months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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 3 
Date of First Enrollment (India)   02/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  02/11/2025 
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 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  
Introduction: Moderate Acute Malnutrition (MAM) is a prevalent condition that arises when individuals do not receive adequate nutrients to maintain optimum health. It is characterized by weight-for-height or BMI-for-age deficits, predisposing individuals to increased morbidity, impaired immunity, and developmental delays. Malnutrition remains a significant public health concern, particularly in the childhood, where rapid physical and cognitive development demands adequate nutrition. It is particularly prevalent in developing countries and is often exaggerated by factors like poverty, food insecurity inadequate access to healthcare.
Mild and moderate malnutrition make up the greatest portion of malnourished children and account for more than 80% of malnutrition associated death. It is therefore vital to intervene in children with mild and moderate malnutrition at the community level before the develop complications. There was a low reduction in undernutrition in the country over the past years, especially in stunting. Yet we continue to have the highest burden of childhood undernutrition in the world.
Homoeopathy is a system of medicine which is considered as safe and effective form of treatment from children to adults. Homoeopathy has distinct advantage for treatment of ailments of children, the therapy is safe, effective and economical.
In conventional system of medicine, supplementing foods and vitamins are the modes of treatment in nutritional problems.
Supplementary therapy with food and vitamin should be given continuously as it is seen that whenever supplement stop the disorder reappears gradually and sometimes adverse effect of supplement are also seen. These supplements are costly, so low socioeconomic people cannot afford it, meanwhile nutritional problems are seen in poor population. Homoeopathic constitutional approach will solve this issue Since this problem is dealt at the fundamental miasmatic level by giving homoeopathic similimum in the form of potent medicines, leading to correction in mal-absorption and mal-assimilation indirectly, correcting the metabolism errors of constitution, and maintaining the nutritional status of a person more effectively for a long lasting.

Primary Objective: To study the effectiveness of Individualized Homoeopathic medicines with personalized diet plan in the management of Moderate Acute Malnutrition among children. 
Secondary Objective: To study the patterns in assessment of growth among children. 
Methodology:  
I) Type of study design: Experimental Non-Controlled Study
II) Study setting: Out Patient Department of Institution.
III) Duration of study: 18 Months
IV) Study population: Clinically diagnosed cases of Acute Moderate Acute Malnutrition in children 5-10 Years of age.
V) Method of selection of study subjects
a) Inclusion Criteria:
1. Clinically diagnosed cases of MAM according to WHO growth standards & IAP (BMI For age <-2SD OR Weight-for-Height Z Scores between -2SD to -3SD)
2. Patients of 5-10 years of age.
3. Patients of all genders.
b) Exclusion Criteria:
1. Suspected cases of congenital anomalies like cystic fibrosis, Phenylketonuria, Inborn errors of metabolism, Turners & Downs Syndrome.
2. Patient with endocrine disorders such as Growth hormone deficiency, Hypothyroidism, Hyperthyroidism, Juvenile Diabetes.
3. Patients with metabolic disorders like Galactosemia, Homocystinuria.
4. Suspected cases of malignancy.
5. Sever acute malnutrition.
6. Suspected immunocompromised patients. 
VI) Operational Definition: Moderate Acute Malnutrition (MAM) is defined as a weight-for-height z-score (WHZ) between -2 and -3 standard deviations below the median of the WHO child growth standards, or a mid-upper arm circumference (MUAC) between 115 mm and 125 mm in children aged 6–59 months, without the presence of bilateral pitting oedema.

Specification of instruments & related measurements:
1)Weight Measurement
a)Instrument: UNICEF-recommended electronic weighing scale with a precision of 100 g.
b)Procedure: The child is weighed with minimal clothing, without shoes. 
c)Measurement Unit: Kilograms (kg) to the nearest 0.1 kg.
2)Height/Length Measurement
a)Instrument: Stadiometer for children over 2 years b) Procedure: Measured barefoot with the head in the Frankfort horizontal plane.
c)Measurement Unit: Centimeters to the nearest 0.1 cm.
3) Body Mass Index (BMI) Formula: 
a)BMI = Weight (kg) / [Height (m)] ²
b)Instrument: Uses measurements from weight and height instruments described above.
c) Unit: kg/m²

Sample size:Though total sample size calculated os 48, in this study minimum 50 patients will be taken. 
Sampling technique:Non probability Purposive sampling 
Study instrument/ Data collection tools:
1. Complete Homoeopathic Case Taking Proforma to form totality.
2. Anthropometric measurements will be used to assess before and after the treatment for MAM.
3. UNICEF-recommended electronic weighing scale with a precision of 100 g & a stadiometer will be used to measure weight & height respectively. 
4. Appropriate reference books like Paediatrics textbooks, Homoeopathic Materia Medica books, Homoeopathic Repertory books, Medicine books, Surgery books, Pathology books, different Homoeopathic journals, research articles will be considered.
5. Appropriate software will be used for repertorization of case
Data management and analysis procedure:
1. Framing of Totality of symptoms- Will be done as per the guidelines of Homoeopathy.
2. Selection of Remedy- Individualized Homoeopathic Medicines based on Totality of symptoms.
3.  Potency will be selected based on the susceptibility of each case & will be changed when required.
4. Duration of Study- 18 months.
5. Duration of Each Case- 4 Months.
6. Duration of Follow-up of each case- Every two weeks.
Purpose of trialWhile numerous studies have explored conventional therapeutic approaches, including micronutrient supplementation and therapeutic feeding, limited evidence exists regarding the role of homoeopathy as an individualized treatment. Most existing research focuses on the efficacy of homoeopathic remedies in managing general health conditions rather than specific nutritional disorders like MAM. Additionally, there is a lack of well-designed, large-scale clinical trials that evaluate the synergistic effects of homoeopathic treatments alongside tailored dietary interventions. This gap hinders the development of evidence-based guidelines for integrating homoeopathy into malnutrition management strategies, especially in resource-constrained settings where access to conventional therapies may be limited.
 
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