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CTRI Number  CTRI/2024/11/076504 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 27/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Testing Calcarea Phos 6x for reducing symptoms of muscles and joints in people with vitamin D3 deficiency: A clinical study. 
Scientific Title of Study   A double-blind randomized placebo control trial utilizing Calcarea Phos 6x in mitigating musculoskeletal manifestations in individuals with vitamin D3 deficiency. 
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 Aswani P U 
Designation  PG scholar 
Affiliation  Bharati Vidyapeeth deemed to be university Homoeopathic medical college and hospital 
Address  Bharati Vidyapeeth deemed to be university Homoeopathic medical college, hospital, Department of postgraduates, and research centre , Pune-Satara road, Dhankawadi, Katraj, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9207640107  
Fax    
Email  ashwi0107@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Sushma Suresh Manhas 
Designation  Head of the department 
Affiliation  Bharati Vidyapeeth deemed to be university Homoeopathic medical college and hospital 
Address  Bharati Vidyapeeth deemed to be university Homoeopathic medical college, hospital, Department of postgraduates, and research centre , Pune-Satara road, Dhankawadi, Katraj, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9822322533  
Fax    
Email  sushma.manhas@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Dr Aswani P U 
Designation  PG scholar 
Affiliation  Bharati Vidyapeeth deemed to be university Homoeopathic medical college and hospital 
Address  Bharati Vidyapeeth deemed to be university Homoeopathic medical college, hospital, Department of postgraduates, and research centre , Pune-Satara road, Dhankawadi, Katraj, Pune

Pune
MAHARASHTRA
411043
India 
Phone  9207640107  
Fax    
Email  ashwi0107@gmail.com  
 
Source of Monetary or Material Support  
BVDU Homoeopathic Medical College and Hosapital, Dept. of post graduation and research centre,Department of organon of medicine , Pune , Maharashtra-411043 
 
Primary Sponsor  
Name  Dr Aswani P U 
Address  Bharati Vidyapeeth deemed to be university Homoeopathic medical college and hospital, Department of postgraduate, and research Center, Pune-Satara road, Dhankawadi, Katraj , Pune-411043 
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 Aswani P U  BVDU Homoeopathic Medical College, Department of Post Graduation and Research centre  Bharati Vidyapeeth deemed to be university Homoeopathic medical college, hospital, Department of postgraduates, and research centre , Pune-Satara road, Dhankawadi, Katraj, Pune
Pune
MAHARASHTRA 		 09207640107

ashwi0107@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Bharati Vidyapeeth(DTU)HMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E559||Vitamin D deficiency, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Calcarea Phosphorica 6x  Homoeopathic medicine Calcarea Phosphorica in the form of biochemic tablets will be given. Dose: 6x. Route of administration : oral . Duration of therapy: 3 months. 
Comparator Agent  Sac Lac  Sac lac in the form of pills. Dose: 4 pills twice a day. Route of administration: oral. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Patient attending OPD who falls short of VDIP score will be included for the study.
2.Age group:18 to 45 years.
3.Patients of both sexes.
4.Patients irrespective of their community or socio-economic status.
5.Patient who has given the consent flr the study. 
 
ExclusionCriteria 
Details  1. Patient is already under vitamin D supplementation.
2.Pregnant and lactating woman.
3.Patient having chronic illness or are critically ill.
4. Patient having defined life-threatening pathology. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of Calcarea Phos 6x in mitigating manifestations related to the musculoskeletal system in individuals with Vitamin D3 deficiency.  3 months with follow-up in each 15 days 
 
Secondary Outcome  
Outcome  TimePoints 
To study the role of psora in deficiency diseases.  3 months with follow-up in each 15 days. 
To assess symptomatic improvement in vitamin D3 deficiency before and after the treatment.  3 months with follow-up in each 15 days along with serum vitamin D3 levels before and after treatment. 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   18/11/2024 
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="6"
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
Modification(s)  		 This is a randomised, double-blind, placebo-controlled clinical study. The primary objective of the study is to assess the efficacy of Calcarea phos 6x in mitigating manifestations pertaining to the musculoskeletal system in individuals with vitamin D3 deficiency. Minimum 52 patients at Bharati Vidhyapeeth (deemed to be a university) Homoeopathic Medical College and Hospital will be enrolled in the study. Patient scoring VDIP score 7 or above will be selected, with 52 participants split into two groups: 26 receiving a placebo and 26 receiving Calcarea phos 6x. Randomization will occur through a coin toss. Head will be control group and tail will be treatment group. Follow-up occurs every 15 days for 3 months, measuring serum vitamin D3 levels before and after treatment. The final assessment will determine changes in vitamin D3 levels. 
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