CTRI/2025/04/085258 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On:
21/04/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Homeopathy Screening
Study Design
Cluster Randomized Trial
Public Title of Study
Homoeopathy for Vitamin D deficiency: a public health program
Scientific Title of Study
Public health program to assess the prevalence of Vitamin-D deficiency and its management with homoeopathic medicine
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 Renu Mittal
Designation
Research Officer/ Scientist-4
Affiliation
Central Council for Research in Homoeopathy
Address
Room number 304, SCSP cell, CCRH Headquarters, 61-65, Institutional area, opposite D-block, Janakpuri, New Delhi
South West DELHI 110058 India
Phone
9717511115
Fax
Email
renumittal8@gmail.com
Details of Contact Person Scientific Query
Name
Dr Renu Mittal
Designation
Research Officer/ Scientist-4
Affiliation
Central Council for Research in Homoeopathy
Address
Room number 304, SCSP cell, CCRH Headquarters, 61-65, Institutional area, opposite D-block, Janakpuri, New Delhi
South West DELHI 110058 India
Phone
9717511115
Fax
Email
renumittal8@gmail.com
Details of Contact Person Public Query
Name
Dr Divya Taneja
Designation
Research Ofiicer (H)/Scientist-3
Affiliation
Central Council for Research in Homoeopathy
Address
Room number 309, Public Health cell, CCRH Headquarters, 61-65, Institutional area, opposite D-block, Janakpuri, New Delhi
South West DELHI 110058 India
Phone
9810305068
Fax
Email
drdivyataneja@gmail.com
Source of Monetary or Material Support
Central Council for Research in Homoeopathy, 61-65, institutional area, opposite D-block, Janakpuri, New Delhi (110058)
Primary Sponsor
Name
Central Council for Research in Homoeopathy
Address
61 65 Institutional area D Block Janakpuri New Delhi 110058
Type of Sponsor
Government funding agency
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 14
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Amit Shrivastava
Central Research Institute for Homoeopathy
Room no. 104, department of SCSP, Central Research Institute for Homoeopathy, ST/NH Sector 02, Jankipuram Extension, Near Vithouli Crossing, Lucknow- 226031, Uttar Pradesh Lucknow UTTAR PRADESH
9140577532
dramit911@gmail.com
Dr Uttam Singh
Central Research Institute for Homoeopathy
Room no. 101, department of SCSP, Central Research Institute for Homoeopathy, Sec-26, Pratap Nagar, Jaipur -302033, Rajasthan Jaipur RAJASTHAN
9899144235
druttam01@gmail.com
Dr G R C Reddy
Clinical Research Unit for Homoeopathy
Room no. 104, department of SCSP, Clinical Research Unit for Homoeopathy, Srabanam Campus, Old Maternity Hospital Campus, Tirupati - 517507, Andhra Pradesh Chittoor ANDHRA PRADESH
9441208007
crutpt@yahoo.co.in
Dr Prabhat Tiwari
Clinical Research Unit for Homoeopathy
Room no. 104, department of SCSP, Clinical Research Unit for Homoeopathy, 14,6th Cross, Jawahar Nagar, Puducherry-605005 Pondicherry PONDICHERRY
9718305515
drprabhattiwari15@gmail.com
Dr Tanya Aggarwal
Clinical Research Unit for Homoeopathy
Room no. 101, department of SCSP, Clinical Research Unit for Homoeopathy, Choto Padhuram Jote, District Darjiling, West Bengal, 734012 Darjiling WEST BENGAL
9873744058
dr.tanyaaggarwal@gmail.com
Dr Shweta Gautam
Dr D.P. Rastogi Central Research Institute for Homoeopathy
Room number 104, department of SCSP, Dr D.P. Rastogi Central Research Institute for Homoeopathy, A-1/1. Sector-24, Gautam Buddh Nagar Noida- 201301 Uttar Pradesh Gautam Buddha Nagar UTTAR PRADESH
9999566890
dr.shwetagtm@gmail.com
Dr Arti Soren
Dr. Anjali Chatterjee Regional Research Institute for Homoeopathy
Room no. 101, department of SCSP, Dr Anjali Chatterjee Regional Research Institute (Homoeopathy), 50, Rajendra Chatterjee Road, Alambazar, Kolkata, West Bengal 700035 Kolkata WEST BENGAL
977837577
arti4soren5@gmail.com
Dr D Karthikeyan
Homoeopathy Research Institute for Disabilities
Room no. 102, department of SCSP, Homoeopathy Research Institute for Disabilities, Room No. 136, NIEPMD Campus, ECR, Muttukadu, Chennai- 603112 Tamil Nadu Chennai TAMIL NADU
8281488685
drkarthikeyanmd@gmail.com
Dr Dhanraj Kumar Rana
National Homoeopathy Research Institute in Mental Health
Room no. 103, department of SCSP, National Homoeopathy Research Institute in Mental Health, Sachivothamapuram, Kottayam- 68653 Kerala Kottayam KERALA
9496470061
dr.dkrana123@gmail.com
Dr Ashish Shivadikar
Regional Research Institute for Homoeopathy
Room no. 102, department of SCSP, Regional Research Institute for Homoeopathy, Plot No. 38-39, Sector-18, Kharghar, Navi Mumbai- 410210
Mumbai Mumbai (Suburban) MAHARASHTRA
7021436030
ashishshivadikar@gmail.com
Dr Deepthi Gilla
Regional Research Institute for Homoeopathy
Room no. 107, department of SCSP, Regional Research Institute for Homoeopathy, OUB-32, Street No. 4, Vikram Puri, Habsiguda, Hyderabad - 500007 Telangana Hyderabad TELANGANA
8111990221
drdeepthigilla@gmail.com
Dr Maneet Parewa
Regional Research Institute for Homoeopathy
Room no. 108, department of SCSP, Regional Research Institute for Homoeopathy, Rabha Bhawan Khalipara, Tari Campus (Ayurveda) Old Building, Borsojali Bhetapara, Guwahati- 781028, Assam Bongaigaon ASSAM
8800370151
parewamnt@gmail.com
Dr Papiya Chanda
Regional Research Institute for Homoeopathy
Room no. 108, department of SCSP, Regional Research Institute for Homoeopathy, JK Kobrapara Road, Khumulwng, Agartala, Tripura - 799045 West Tripura TRIPURA
9903481166
papiyachanda360@gmail.com
Dr Pradhan
Regional Research Institute for Homoeopathy
Room no. 104, department of SCSP, Regional Research Institute for Homoeopathy, CCRH Building Marchikote Lane, Near Labanikhia Chhak, Puri- 752001(Odisha) Puri ORISSA
9475996463
rri_puri@yahoo.co.in
Details of Ethics Committee
No of Ethics Committees= 15
Name of Committee
Approval Status
Central Ethics Committee of Central Council for Research in Homoeopathy, New Delhi
Approved
IEC, RRIH, Jaipur
Approved
Institutional Ethics Committee, CRIH, Lucknow
Approved
Institutional Ethics Committee, CRUH, Puducherry
Approved
Institutional Ethics Committee, CRUH, Tirupati
Approved
Institutional Ethics Committee, Dr Anjali Chatterjee Regional Research Institute Homoeopathy, Kolkata
Approved
Institutional Ethics Committee, Dr D.P. Rastogi Central Research Institute for Homoeopathy, Noida
Approved
Institutional Ethics Committee, HRID, Chennai
Approved
Institutional Ethics Committee, NHRIMH, Kottayam
Approved
Institutional Ethics Committee, RRIH, Agartala
Approved
Institutional Ethics Committee, RRIH, Guwahati
Approved
Institutional Ethics Committee, RRIH, Hyderabad
Approved
Institutional Ethics Committee, RRIH, Mumbai
Approved
Institutional Ethics Committee, RRIH, Puri
Approved
Institutional Ethics Committee, RRIH, Siliguri
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: E55||Vitamin D deficiency,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Calcarea Phosphoricum 6X
Drug recorded in homoeopathic Pharmacopeia of India (not a new drug) will be prescribed as per principles of homoeopathy. Calcarea phosphoricum 6X manufactured by Good Manufacturing Practice (GMP) compliant pharmaceutical firms will be prescribed for age group 6-18 years, it will be given 4 tablets once a day, and for the age group 18- 65 years, it will be given 4 tablets twice a day. Calcarea phosphoricum 6x will be administered through oral route. Duration of intervention: 12 months
Intervention
Individualised Homoeopathic Medicine
The individualized homoeopathic medicines (As per Homoeopathic pharmacopoeia of India/ materia medica) manufactured by Good Manufacturing Practice (GMP) compliant pharmaceutical firms. Indicated homoeopathic medicines will be dispensed as per principles of Homoeopathy Along with medicines, dietary/lifestyle modifications will be suggested. Medicines will be given through Oral route, on an empty stomach in sugar globules of standard size 30. No new drug will be used. Duration of intervention: 12 months.
Inclusion Criteria
Age From
6.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
Individuals coming to the medical camps for health checkups.
Children aged 6 to 17 years, and adult individuals aged 18 to 65 years of both sexes.
Persons willing to participate in the program and give consent (6 years to less than 12 years shall provide verbal assent & consent of parent also their parent or guardian can answer the questions for them, 12 years to less than 18 years shall provide written assent and consent of parent and adults of 18 to 65 years shall provide written consent) to draw blood for further examinations.
Persons who can be interviewed directly and who can respond to the questions of the survey
Persons with vitamin D Insufficiency (more than 20 to less than 30 ng/ml)
ExclusionCriteria
Details
Persons above 65 years of age
Persons with self-reported severe bleeding disorders such as haemophilia or thrombocytopenia, or Anticoagulant Medication (currently or in the last 3 months)
Participants exhibiting symptoms of active infection, such as fever, chills, or localized signs of infection at the venipuncture site.
Participants with severe deficiency of Vitamin D (less than 5 ng/ml), Moderate deficiency (6-19 ng/ml) and toxicity
Participants unable to come for regular follow-ups for a minimum of two follow-ups.
Participants refusing consent for the homoeopathic treatment.
Pregnant and lactating women.
Persons with identified Hepato-renal conditions
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
Centralized
Blinding/Masking
Participant and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Change in serum Vitamin-D levels
Baseline, at 6 months and at 12 months
Secondary Outcome
Outcome
TimePoints
prevalence of Vitamin D levels
baseline
Change in serum Calcium levels
baseline, at 6 months and at 12 months
Change in serum Phosphate levels
Baseline, at 6 months and at 12 months
Change in serum Magnesium levels
Baseline, at 6 months and at 12 months
Change in serum Uric Acid levels
Baseline, at 6 months and at 12 months
Change in Alkaline Phospatase levels
Baseline, at 6 months and at 12 months
Target Sample Size
Total Sample Size="1600" Sample Size from India="1600" 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
N/A
Date of First Enrollment (India)
09/05/2025
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="2" 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 is a public health program where in within the identified blocks and villages screening for Vitamin D deficiency would be undertaken to identify the prevalence of Vitamin D deficiency/insufficiency as well as toxicity levels in the participants. The participants identified with vitamin D deficiency/insufficiency, which is serum vitamin D levels between 20 ng/ml to 30 ng/ml, will be recruited to the study. Cluster randomization will be conducted where in one group will be advised Individualised Homoeopathic Medicine and the other group will be given Calcarea Phosphoricum 6x. Along with this both groups will be given dietary advice as well as required IEC material will be provided to ensure nutritional compliances. No new drugs will be used in the study. Vitamin D levels will be again tested at 6 months and at 12 months post intervention to assess change in the vitamin D levels in order to identify the usefulness of homoeopathic treatments.