| CTRI Number |
CTRI/2025/09/094682 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Pilot Study on Individualized Homoeopathy, Biochemic Remedies, and Nutrition in Improving Micronutrient Levels in School Children. |
|
Scientific Title of Study
|
Comparing Individualized Homoeopathic Medicine, Biochemic medicines and
Nutritional advise in alleviating Micronutrient deficiencies: A pilot randomized placebo
controlled trial in school going children. |
| 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 Divya Taneja |
| Designation |
Research Officer(H) Scientist 3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no 309,Department:Public Health. Central Council for Research in Homoeopathy, 61-65 Institutional area, Opposite D Block, Janakpuri, New Delhi, India,Pincode-110058
South West
DELHI
110058
India |
| Phone |
9810305068 |
| Fax |
|
| Email |
drdivyataneja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Taneja |
| Designation |
Research Officer(H) Scientist 3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no 309,Department:Public Health. Central Council for Research in Homoeopathy, 61-65 Institutional area, Opposite D Block, Janakpuri, New Delhi, India,Pincode-110058
DELHI
110058
India |
| Phone |
9810305068 |
| Fax |
|
| Email |
drdivyataneja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Renu Mittal |
| Designation |
Research Officer(H) Scientist 4 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Room no 304, Department: Scheduled Caste Sub plan. Central Council for Research in Homoeopathy, 61-65 Institutional area, Opposite D Block, Janakpuri, New Delhi,India, Pincode-110058
South West
DELHI
110058
India |
| Phone |
9717511115 |
| Fax |
|
| Email |
renumittal8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy, 61-65 Institutional area, opposite D block, Janakpuri, New Delhi, India, Pin code - 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Homoeopathy, New Delhi |
| Address |
Jawahar Lal Nehru Chikitsa Avum Anusandhan Bhawan,61-65, Institutional Area, Opposite D Block Janakpuri 110058 |
| Type of Sponsor |
Research institution |
|
|
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 Padmalaya Rath |
Dr DP Rastogi Central Research Institute of Homoeopathy, Noida, UP |
Room no.-1,Department of Homoeopathy public health, Dr D.P. Rastogi Central Research Institute of Homoeopathy, Noida, A-l/1. Sector-24, Gautam Budh Nagar Noida- 201301, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
9811704560
drpadmalaya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CENTRAL ETHICS COMMITTEE OF CENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E50-E64||Other nutritional deficiencies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Biochemic Medicines and
Nutritional Counselling |
Indicated Biochemic
Medicine, twice a day
for 6 months as per principles of Homoeopathy.
Nutritional counselling
designed for each individual
child based on general
principles of balanced,
diverse diets rich in fruits,
vegetables, lean proteins,
dairy, etc. |
| Intervention |
Individualized homoeopathic medicines and Nutritional Counselling |
Individualised homoeopathic
medicines in centesimal potency for 6 months. Nutritional counselling designed for each individual child based on general principles of balanced, diverse diets rich in fruits, vegetables, lean proteins, dairy, etc. |
| Comparator Agent |
Placebo and Nutritional Counselling |
Placebo identical in taste, shape, and color to the homoeopathic medicine will be prescribed. Nutritional counselling designed for each individual child based on general principles of balanced, diverse diets rich in fruits, vegetables, lean proteins, dairy, etc. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Participants of all genders in the age group of 6-17 years. (Class 1- Class 12)
Diagnosed with one or more micronutrient deficiencies. |
|
| ExclusionCriteria |
| Details |
Children where parents refuse consent and/or child refuses assent.
Children currently taking micronutrient supplements or undergoing treatment for micronutrient deficiencies within the last 30 days.
Children currently on treatment with corticosteroids, or those who have taken steroids in last 6 weeks.
Children with severe malnutrition or those requiring hospitalization for malnutrition.
Children with severe micronutrient deficiencies, requiring immediate intervention.
Children with psychological or behavioral issues, suffering from any mental illness like Autism, Attention deficit hyperactive disorder.
Children with concurrent heart, liver or renal conditions or chronic malignancy selfreported bleeding disorder or haemoglobinopathy, self reported cases of drug reactions, autoimmune diseases, tuberculosis etc.
Raised CRP levels greater than 10.0 mg/dl. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in serum levels of the deficient micronutrients (Vitamin B12, D, Iron, Calcium, Zinc, Magnesium and Iodine) across the three treatment groups. |
Baseline, 3 Months, 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identification of indicative prevalence range of single micronutrient and multiple micronutrient deficiencies (two or more deficiencies in the same child) in school going children |
Baseline |
| Identification of Screening-to-recruitment ratio |
Baseline |
| Clinical improvement in deficiency symptoms (e.g., fatigue, cognitive function, growth parameters) |
Baseline, 1 Months, 2 Months, 3 Months, 4 Months, 5 Months, 6 Months |
| Identification of symptoms linked to micronutrient deficiencies |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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
|
Study titled "Comparing Individualized Homoeopathic Medicine, Biochemic medicines and Nutritional advise in alleviating Micronutrient deficiencies: A pilot randomized placebo controlled trial in school going children." is Pilot, Single blind, randomized, controlled trial & would be conducted in identified schools through DDPRCRIH Noida for a period of 1 year with a primary objective to identify single and multiple micronutrient deficiencies in school children which will be assessed at baseline, 3 months and 6 months across the three treatment groups. Sample size is 120 participants. There will be 40 participants in each group. Group 1 will receive Individualized homoeopathic medicines in centesimal potency will be prescribed as per the principles of Homoeopathy for 6 months and Nutritional Counselling. Group 2 will receive Biochemic Medicines, twice a day for 6 months and Nutritional Counselling. Group 3 will receive Placebo and Nutritional Counselling. Participants diagnosed with one or more micronutrient deficiencies of all genders in age group of 6-17 years will be included in study. Complete haematological parameters will be assessed at baseline, 3 months and after 6 months of treatment. Clinical assessment including nutritional assessment will be done at baseline and at end of each month upto 6 months. |