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CTRI Number  CTRI/2025/12/099675 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 19/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Study in Postmenopausal Women with Osteoporosis Comparing Two Homoeopathic Interventions—Individualized Treatment and Calcarea Phosphorica—Using T-score as the Primary Outcome. 
Scientific Title of Study   A Comparative Study to Evaluate the Efficacy of Individualized Homoeopathic Medicine versus Calcarea Phosphoricum 12x in Postmenopausal Women with Osteoporosis using T-Score 
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 Aashish Rana 
Designation  PG Scholar 
Affiliation  Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University 
Address  OPD Room number 110 Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University Waghodia Vadodara Gujarat 391760 India

Vadodara
GUJARAT
391760
India 
Phone  9054263301  
Fax    
Email  aashishr2404@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Samir Gupta 
Designation  BHMS, MD Homoeopathy, Associate Professor PG Department of Practice of Medicine 
Affiliation  Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University 
Address  PG Department of Practice of Medicine Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University Waghodia Vadodara Gujarat 391760 India

Vadodara
GUJARAT
391760
India 
Phone  7709396584  
Fax    
Email  samir.gupta87142@paruluniversity.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Aashish Rana 
Designation  PG Scholar 
Affiliation  Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University 
Address  Jawaharlal Nehru Homoeopathic Medical College and Hospital Parul University Waghodia Vadodara Gujarat 391760 India

Vadodara
GUJARAT
391760
India 
Phone  9054263301  
Fax    
Email  aashishr2404@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University, Waghodia, Vadodara, Gujarat 391760 India 
 
Primary Sponsor  
Name  Jawaharlal Nehru Homoeopathic Medical College and Hospital  
Address  Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University, Waghodia 391760 
Type of Sponsor  Private medical college 
 
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 Aashish Rana  Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University  OPD Room number 110 Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University, Waghodia, Vadodara, Gujarat 391760 India
Vadodara
GUJARAT 		 9054263301

aashishr2404@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jawaharlal Nehru Homoeopathic Medical College and Hospital institutional Ethics Committee For Human Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M810||Age-related osteoporosis without current pathological fracture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Biochemic medicine names Calcarea Phosphoricum 12x  Biochemic medicine named Calcarea Phosphoricum 12x based on principles of Schuesslers twelve tissue remedies for 6 months, and follow up will be taken monthly. 
Intervention  Individualised Homoeopathic Medicine   Individualised Homoeopathic Medicine selected using Cardinal principles of Homoeoopathy for 6 months, follow up will be taken monthly  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1) Confirmed diagnosis of osteoporosis done with Bone Mineral Density Test BMD Test
2) Age group between 45 to 60 years
3) Patients who are willing to participate & give written informed consent 
 
ExclusionCriteria 
Details  1) Patients having fractures
2) Patients of severe osteoporosis T score of minus two points five with fracture
3) Patients with comorbidities
4) Other major illness such as HIV/AIDS, TB, cardiac condition, renal condition 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
- No improvement
- Mild improvement
- Moderate improvement
- Significant improvement 		 6 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   N/A 
Date of First Enrollment (India)   01/01/2026 
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="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   Osteoporosis is a systemic skeletal disorder characterized by reduced bone strength and deterioration of bone microarchitecture, leading to an increased risk of fractures. Postmenopausal women are particularly vulnerable due to estrogen deficiency, which accelerates bone resorption. Globally, osteoporosis affects a significant proportion of the population, with higher prevalence in women and notably high rates reported in developing countries, including India. In Indian postmenopausal women, the prevalence shows wide regional variation, highlighting the magnitude of the public health burden.

The T-score obtained from DEXA scanning is the gold standard for diagnosing and monitoring osteoporosis, providing a reliable and objective measure of bone mineral density. In homoeopathic practice, both biochemic remedies and individualized constitutional treatment are used in managing osteoporosis. Calcarea Phosphoricum 12X is a well-established biochemic remedy known to support bone metabolism, calcium assimilation, and bone healing, while individualized homoeopathic medicines aim to address the patient holistically.

This study is designed to evaluate and compare the efficacy of individualized homoeopathic medicines and Calcarea Phosphoricum 12X in postmenopausal women with osteoporosis, using T-score as an outcome measure over a 6-month period. Additionally, it seeks to identify commonly indicated individualized homoeopathic remedies used in the management of osteoporosis over an 18-month duration.
 
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