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CTRI Number  CTRI/2026/02/104359 [Registered on: 19/02/2026] Trial Registered Prospectively
Last Modified On: 17/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Scope of biochemic five phos six x compared to homeopathic medicine on growth parameters in underweight children under five years of age group 
Scientific Title of Study   SCOPE OF BIOCHEMIC COMBINATION OF FIVE PHOS 6X VIS-À-VIS INDICATED HOMOEOPATHIC MEDICINE ON ANTHROPOMETRIC MEASUREMENTS AMONG THE UNDERWEIGHT CHILDREN UNDER 5 YEARS OF AGE GROUP (GRADE I AND GRADE II IAP CLASSIFICATION OF PROTEIN ENERGY MALNUTRITION): SINGLE-BLIND, RANDOMIZED CONTROL 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 Omkar Deepak Anavkar 
Designation  Ph D Scholar 
Affiliation  Dr M L Dhawale Memorial Homoeopathic Institute 
Address  Room Number three hundred and four Doctor M L Dhawale Memorial Homoeopathic Institute Department of Paediatrics Palghar Boisar Road Opposite S T Workshop

Palghar
MAHARASHTRA
401404
India 
Phone  7039499102  
Fax    
Email  omkaranavkar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chandrasekhar Goda 
Designation  HOD and Professor of Dept. of Paediatrics 
Affiliation  Dr M L Dhawale Memorial Homoeopathic Institute 
Address  Room Number three hundred and five Doctor M L Dhawale Memorial Homoeopathic Institute Department of Paediatrics Palghar Boisar Road Opposite S T Workshop

Palghar
MAHARASHTRA
401404
India 
Phone  9322882918  
Fax    
Email  sujchan18@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bipin S Jain 
Designation  Principal 
Affiliation  Dr M L Dhawale Memorial Homoeopathic Institute 
Address  Room Number one hundred and thirty four Doctor M L Dhawale Memorial Homoeopathic Institute Department of Paediatrics Palghar Boisar Road Opposite S T Workshop

Palghar
MAHARASHTRA
401404
India 
Phone  9323690095  
Fax    
Email  principalmldmhi@gmail.com  
 
Source of Monetary or Material Support  
Dr M L Dhawale Memorial Trust Institute Boisar Road Opp S T Workshop District Palghar Maharashtra India 401404 
 
Primary Sponsor  
Name  Dr. M L Dhawale Memorial Trust Hospital, Palghar 
Address  Doctor M L Dhawale Memorial Trust Hospital Palghar Boisar Road Opposite S T Workshop Palghar 401 104 District Palghar Maharashtra India 
Type of Sponsor  Research institution and hospital 
 
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 Omkar Anavkar  Dr M L Dhawale Memorial Homoeopathic Institute  Room no 304 Department of Paediatrics Palghar Boisar road opp ST workshop district Palghar Maharashtra India 401404
Palghar
MAHARASHTRA 		 7039499102

omkaranavkar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, MLDMHI, Palghar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E44||Protein-calorie malnutrition of moderate and mild degree,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Five Phos 6x Group  6X TDS ORALLY FOR 12 MONTHS 
Comparator Agent  Group 2- Indicated homoeopathic medicine group-  The most indicated homoeopathic medicine will be prescribed in an appropriate potency (30, 200, or 1M) and repetition (once per week, three times per week, daily, twice daily, three times daily, or four times daily) administered orally based on the susceptibility of the patient for a total duration of twelve months. 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1 Children diagnosed with Grade one and Grade two malnutrition as per IAP guidelines.

2 Children within the age group of six months to five years.

3 Participants of both genders including boys and girls.

4 Children with recurrent respiratory illnesses such as rhinitis, laryngitis, tonsillitis, and pharyngitis, gastric complaints such as worm infection, constipation, and diarrhoea, skin complaints such as scabies and dermatitis.

5 Cases in which parents or legal guardians provide written informed consent and assent for their children. 
 
ExclusionCriteria 
Details  Children with a known case of any major illness like any congenital anomalies such as cleft lip, cleft palate, or congenital heart disease, tuberculosis or childhood cancer, cystic fibrosis or cerebral palsy. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the efficacy of the biochemic combination of five phos 6x versus indicated homoeopathic medicines on improving anthropometric measurements in underweight children with PEM under 5 years of age group (grade I and grade II IAP classification of PEM) in 12 months.  Time Points: 0 (Baseline), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
To know the commonly used homoeopathic medicines in the management of underweight children under five years of age  At the completion of twelve months of treatment 
To know the commonly used posology in the management of underweight children under five years of age  At the completion of twelve months of treatment 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   04/03/2026 
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="4"
Months="0"
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  

This study is a single blind randomized control trial designed with a primary objective to evaluate and compare the efficacy of a biochemic intervention against indicated homoeopathic medicine in improving the anthropometric measurements of children classified as grade one and grade two protein energy malnutrition as per Indian Academy of Pediatrics classification.


The need for this study stems from the significant global and national burden of undernutrition, particularly in India, where a high percentage of children under five are underweight. Malnutrition is a major public health challenge linked to increased susceptibility to infections, delayed cognitive development, and higher mortality rates. By exploring a homoeopathic approach, this study seeks to provide a potentially effective and safe alternative or complementary treatment to conventional methods.


The methodology involves recruiting children based on defined inclusion and exclusion criteria. The randomization sequence will be generated using a computer generated random number table to ensure unbiased allocation into two study groups. Allocation will be concealed from the investigator and participants at the point of enrollment using sequentially numbered opaque sealed envelopes, which will be opened only after the participant is officially enrolled. Participants will receive either biochemic combination of five phos six x or an indicated homoeopathic medicine. This is a single blind study where the participants remain unaware of their specific group assignment, while the investigator remains aware to facilitate the administration of individualized medicines.


The primary outcome will be measured through changes in anthropometric parameters including weight, height, mid upper arm circumference, and head circumference at monthly intervals for twelve months to evaluate improvement in nutritional status. The findings from this research are expected to contribute valuable data to the field of homoeopathy and offer a potential therapeutic option for addressing pediatric undernutrition.

 
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