| CTRI Number |
CTRI/2026/02/102791 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
01/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Individualised Homoeopathic medicine in comparison with biochemic medicine calcaria phosphorica 6x in the management of weak and brittle bones among women after menopause |
|
Scientific Title of Study
|
Studying Effectiveness of Individualised Homoeopathic medicine versus calcaria Phosphorica 6x in the management of Osteoporosis among postmenopaual women - A Comparative study |
| 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 Bhagyashri Babanrao Wankhede |
| Designation |
PhD scholar |
| Affiliation |
Dhondhumama sathe Homoeopathic Medical College and NMRM Hospital Pune |
| Address |
23 Karve Rd Khilarewadi Erandwane Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9921878835 |
| Fax |
|
| Email |
dr.shriwankhede26@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Maneesha vivek Solanki |
| Designation |
Principal |
| Affiliation |
Dhondhumama sathe Homoeopathic Medical College and NMRM Hospital Pune |
| Address |
Dhondumama Sathe Homoeopathic medical college and NMRMH hospital Pune 23 karve Road khillarewadi Erandwana Pune, Maharashtra
Pune
MAHARASHTRA
411004
India |
| Phone |
9822839740 |
| Fax |
|
| Email |
principaldshmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagyashri Babanrao Wankhede |
| Designation |
PhD scholar |
| Affiliation |
Dhondhumama sathe Homoeopathic Medical College and NMRM Hospital Pune |
| Address |
23 Karve Rd Khilarewadi Erandwane Pune
Pune
MAHARASHTRA
411004
India |
| Phone |
9921878835 |
| Fax |
|
| Email |
dr.shriwankhede26@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| Dhondumama Sathe Homoeopathic Medical College and NMRM Hospital Pune Maharashtra 411004 |
|
|
Primary Sponsor
|
| Name |
Dr Bhagyashri Babanrao Wankhede |
| Address |
23 karve Rd Khilarewadi Erandwane Pune Maharashtra 411004 |
| Type of Sponsor |
Other [Self ] |
|
|
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 Bhagyashri Wankhede |
Dhondumama sathe Homoeopathic medical College and NMRMH Hospital |
Out patient department No 2 Practice of Medicine
23 karve Road khilarewadi Erandwana pune 4411004
Pune
MAHARASHTRA |
9921878835
dr.shriwankhede26@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Dhondumama Sathe Homoeopathic Medical College and NMRM Hospital Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M818||Other osteoporosis without currentpathological fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcaria Phosphorica 6x |
Total sample size is 146 out Of it Group B will comprise 73 Cases that will be treated With biochemic medicine Calcaria Phosphorica in a fix Potency and repetition for all i.e 6X 5tablets once a day for 3 Months Then further repetition will be decided according to the requirement of a case |
| Intervention |
Individualised Homoeopathic Medicine |
Total sample size is 146 out of it Group A will comprise 73 cases and will be treated with Individualised Homoeopathic Medicine in a fix potency and dose for all i.e. 30CH 5 globules once a day in a crushed or power form for 3 months further repetition of Medicine will be decided according to requirement of case |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Posenopausal women having their BMD T score less than or equal to -2.5 will be included in the study |
|
| ExclusionCriteria |
| Details |
Patient having associated endocrinal disorder like Adrenal insufficiency,Cushing Syndrome,Central adiposity ,Diabetes mellitus Type1 and 2,Hyperparathyroidism,Thyrotoxicosis |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine effectiveness of Individualised Homoeopathic Medicine with compare to Calcaria Phosphorica 6x in the management of Osteoporosis among post menopausal women |
1year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine effectiveness of Individualised Homoeopathic Medicine with compare to Calcaria Phosphorica 6x in improving BMD Tscore among postmenopaual women |
1year |
|
|
Target Sample Size
|
Total Sample Size="146"
Sample Size from India="146"
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)
|
16/02/2026 |
| 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="3"
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 aims to compare the effectiveness of Individualised Homoeopathic medicines with Calcarea Phosphorica 6X in the management of osteoporosis among post menopausal women. Background: Osteoporosis is a widespread condition leading to reduced bone density and fragility fractures, with high prevalence in Indian post menopausal women. Conventional treatments (bisphosphonates, calcium, vitamin D) have side effects and limitations, prompting the need for safer, cost effective alternatives. Rationale: Homoeopathy with its holistic and individualised approach, may offer effective management. Calcarea Phosphorica a biochemic tissue salt is traditionally linked to bone health. Few comparative studies exist, highlighting a knowledge gap. Aim: To assess whether individualised homoeopathic medicines are more effective than Calcarea Phosphorica 6X in improving bone mineral density (BMD) and clinical symptoms of osteoporosis. Methodology: Design: Single-blind, randomized comparative clinical trial. Population: 146 post menopausal women with osteoporosis (BMD T-score < -2.5). Group A – Individualised homoeopathic medicines. Group B – Calcarea Phosphorica 6X (fixed dose). Duration: 3 years, with periodic follow-ups. Outcomes: Changes in BMD (DEXA scans) pain (VAS scale) and common osteoporosis symptoms. Expected Contribution: This study will provide evidence on comparative efficacy, possibly positioning Calcarea Phosphorica 6X as a substitute for calcium supplements and enriching literature on homeopathic management of Osteoporosis. |