| CTRI Number |
CTRI/2025/12/098645 [Registered on: 08/12/2025] Trial Registered Prospectively |
| Last Modified On: |
07/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Clinical Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of Homeopathic Treatment in Knee Pain (Osteoarthritis) A Study Using WOMAC Index |
|
Scientific Title of Study
|
To Study The Utility Of A Concise Repertory Of Homeopathic Medicine (Phatak Repertory) In Knee Osteoarthritis Using WOMAC Index |
| 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 Krupa Joshi |
| Designation |
Pg Scholar |
| Affiliation |
Shree B G Garaiya homoeopathic medical college and hospital |
| Address |
Shree B G Garaiya homoeopathic medical college and hospital opd no 3 department of homoeopathic repertory and case taking behind ashapura hotel
Kalipat Rajkot Bhavnagar highway near tramba
Rajkot Shree B G Garaiya homoeopathic medical college and hospital opd no 3 department of homoeopathic repertory and case taking behind ashapura hotel
Kalipat Rajkot Bhavnagar highway near tramba
Rajkot Rajkot GUJARAT 360020 India |
| Phone |
7698594389 |
| Fax |
|
| Email |
krupajoshi421@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nirav manseta |
| Designation |
Professor at department of homoeopathic repertory and case taking |
| Affiliation |
Shree B G Garaiya homoeopathic medical college and hospital |
| Address |
Shree B G Garaiya homoeopathic medical college and hospital opd no 3 department of homoeopathic repertory and case taking behind ashapura hotel
Kalipat Rajkot Bhavnagar highway near tramba
Rajkot Shree B G Garaiya homoeopathic medical college and hospital opd no 3 department of homoeopathic repertory and case taking behind ashapura hotel
Kalipat Rajkot Bhavnagar highway near tramba
Rajkot Rajkot GUJARAT 360020 India |
| Phone |
9998191991 |
| Fax |
|
| Email |
nirav.manseta@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Krupa joshi |
| Designation |
Pg scholar |
| Affiliation |
Shree B G Garaiya homoeopathic medical college and hospital |
| Address |
Shree B G Garaiya homoeopathic medical college and hospital opd no 3 department of homoeopathic repertory and case taking behind ashapura hotel
Kalipat Rajkot Bhavnagar highway near tramba
Rajkot Shree B G Garaiya homoeopathic medical college and hospital opd no 3 department of homoeopathic repertory and case taking behind ashapura hotel
Kalipat Rajkot Bhavnagar highway near tramba
Rajkot Rajkot GUJARAT 360020 India |
| Phone |
7698594389 |
| Fax |
|
| Email |
krupajoshi421@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shree B G Garaiya Homoeopathic Medical College And Hospital Rajkot |
| Address |
Shree B G Garaiya Homoeopathic Medical College And Hospital Opd no 3 Department Homoeopathic Repertory And Case Taking Behind Ashapura Hotel
Kalipat Rajkot Bhavnagar Highway Near Tramba
Rajkot 360020 Gujarat India |
| Type of Sponsor |
Private medical college |
|
|
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 Krupa Joshi |
Shree B G Garaiya Homoeopathic Hospital Rajkot |
Shree B G Garaiya Homoeopathic Medical College And Hospital Department Homoeopathic Repertory And Case Taking Room no 4 Opd Medicine Behind Ashapura Hotel
Kalipat Rajkot Bhavnagar Highway Near Tramba
Rajkot 360020 Gujarat India Rajkot GUJARAT |
7698594389
krupajoshi421@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shree B G Garaiya homeopathic medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M17||Osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient aged 50 – 70 Years of both sexes were include
2 Radiographically confirmed cases of knee Osteoarthritis
3 Primary Knee Osteoarthritis cases include
4 Patient of both the sexes all the religious and culture background
5 Patients who provide written consent for the study |
|
| ExclusionCriteria |
| Details |
1 Other than Primary Knee Osteoarthritis exclude
2 Other joint disease or any systemic disease
3 Patient Taking medicine from other mode of treatment and were not willing to
leave it
4 Immuno compromised patient |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in total WOMAC score (including pain stiffness and physical function subscales) from baseline to the end of the study period following homeopathic prescription based on Phataks Concise Repertory |
12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Overall improvement in general well being of the patient |
12 Months |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
15/05/2026 |
| 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="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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - By writing application to the hospital superintendent of BGGHMS
- For how long will this data be available start date provided 25-12-2027 and end date provided 30-11-2037?
Response (Others) - Total ten years after publication
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Knee osteoarthritis is a highly prevalent degenerative joint disorder especially among the elderly and women leading to chronic pain stiffness and restricted daily activities Conventional treatment mainly provides temporary symptomatic relief and may have side effects whereas homeopathy offers a holistic and individualized approach to management Phatak Repertory being concise and clinically oriented with well defined rubrics for joint pain stiffness modalities and degeneration is valuable in remedy selection for osteoarthritis cases The present study aims to assess the clinical utility of Phatak Repertory in knee osteoarthritis using the WOMAC index as an objective outcome measure Thirty cases will be selected from OPD And IPD and treated individually based on repertorization Pre and post treatment WOMAC scoring will be compared to evaluate improvement If effective results are observed the study may support the usefulness of Phatak Repertory in improving symptoms and functional ability in knee osteoarthritis patients |