| CTRI Number |
CTRI/2025/12/098357 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
efficacy of homoeopathic medicines in reducing knee pain in postmenopausal women |
|
Scientific Title of Study
|
A STUDY TO ASSESS THE EFFICACY OF
HOMOEOPATHIC MEDICINES SELECTED USING
THE RHEUMATIC REMEDIES REPERTORY IN THE
MANAGEMENT OF PRIMARY KNEE
OSTEOARTHRITIS AMONG POSTMENOPAUSAL
WOMEN BY WESTERN ONTARIO AND MCMASTER
UNIVERSITIES OSTEOARTHRITIS INDEX |
| Trial Acronym |
RHEUM-OA Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR DEVIREDDY MADHURI REDDY |
| Designation |
MD SCHOLAR |
| Affiliation |
A M SHAIKH HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL AND PG RESEARCH CENTER |
| Address |
AM Shaikh Homoeopathic Medical College PG Research Centre And Hospital Ground Floor OPD 1 Department of Repertory and
Case Taking PG Section Shaikh Campus Nehru Nagar Belagavi Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8185848099 |
| Fax |
|
| Email |
madhurireddy818@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANGEETA C BELAGAVIMATH |
| Designation |
ASSOCIATE PROFESSOR AND PG GUIDE |
| Affiliation |
A M SHAIKH HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL AND PG RESEARCH CENTER |
| Address |
AM Shaikh Homoeopathic Medical College PG Research Centre And Hospital Ground Floor OPD 1 Department of Repertory and
Case Taking PG Section Shaikh Campus Nehru Nagar Belagavi Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9448875278 |
| Fax |
|
| Email |
drsangeetabelgavimath@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DEVIREDDY MADHURI REDDY |
| Designation |
MD SCHOLAR |
| Affiliation |
A M SHAIKH HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL AND PG RESEARCH CENTER |
| Address |
AM Shaikh Homoeopathic Medical College PG Research Centre And Hospital Ground Floor OPD 1 Department of Repertory and
Case Taking PG Section Shaikh Campus Nehru Nagar Belagavi Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8185848099 |
| Fax |
|
| Email |
madhurireddy818@gmail.com |
|
|
Source of Monetary or Material Support
|
| A M SHAIKH HOMOEOPATHIC MEDICAL
COLLEGE HOSPITAL AND PG RESEARCH
CENTER |
|
|
Primary Sponsor
|
| Name |
DR DEVIREDDY MADHURI REDDY |
| Address |
FLAT 401 CHETHANA BRINDAVANA APTS 10TH MAIN TEMPLE ROAD NRI LAYOUT RAMAMURTHYNAGAR BENGALURU 560016 |
| 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 DEVIREDDY MADHURI REDDY |
AM SHAIKH HOMOEOPATHIC MEDICAL COLLEGE HOSPITAL & P G RESEARCH CENTER |
GROUND FLOOR OPD 1 DEPARTMENT OF REPERTORY AND CASE TAKING AM SHAIKH HOMOEOPATHIC MEDICAL
COLLEGE HOSPITAL & P G RESEARCH CENTER NEHRU NAGAR BELAGAVI
KARNATAKA
Belgaum
KARNATAKA |
8185848099
madhurireddy818@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, (2) ICD-10 Condition: M17||Osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicines selected using the Rheumatic Remedies Repertory |
Homoeopathic medicines will be selected individually for each participant based on totality of symptoms using The Rheumatic Remedies Repertory by H A Roberts Selection will be guided by characteristic symptoms modalities and concomitants related to knee osteoarthritis Potency and repetition will be individualized as per homoeopathic principles and physicians discretion generally in 30C or 200C or 1 M potency Each medicine will be administered orally in medicated globules or pills with follow-up assessments at monthly intervals for 6 months No comparator arm or placebo control will be used |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1 Postmenopausal women with the age group 45to 65 years
2 Clinically diagnosed cases of primary knee osteoarthritis with American College of Rheumatology clinical classification criteria
3 Subjects willing to sign on consent form
4 Women of all kind of occupations |
|
| ExclusionCriteria |
| Details |
1 Subjects currently undergoing other alternative treatments for osteoarthritis of knee
2 Subjects who are undergoing hormonal therapies
3 Subjects who have undergone knee joint replacement surgery
4 Subjects with Comorbidities such as Diabetes Hypertension and other systemic disorders
5 History of any trauma like fractures ligaments and tears
6 Subjects diagnosed with rheumatoid arthritis or any type of inflammatory arthritis like psoriatic arthritis infective arthritis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improved The Western Ontario and McMaster Universities Osteoarthritis Index
score below 60 indicates the improvement in the case after intervention
Not improved The Western Ontario and McMaster Universities Osteoarthritis Index
score above 60 indicates not improvement in the case after intervention |
Baseline and 6 months after initiation of homoeopathic treatment. Clinical follow-up visits will be conducted monthly WOMAC assessments will be performed at baseline and at the end of 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
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)
|
11/12/2025 |
| 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="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Osteoarthritis of the knee is a chronic degenerative joint disorder that causes progressive pain stiffness and functional limitation especially in postmenopausal women Conventional management focuses on pain relief and joint protection but may not address individual susceptibility or constitutional factors Homoeopathy aims to restore balance by prescribing individualized medicines based on the totality of symptoms The Rheumatic Remedies Repertory by HA Roberts is a specialized repertory emphasizing musculoskeletal conditions, offering a structured approach to remedy selection in rheumatic and degenerative diseases objectives To assess the efficacy of individualized homoeopathic medicines selected using the Rheumatic Remedies Repertory in managing primary knee osteoarthritis among postmenopausal women using the Western Ontario and McMaster Universities Osteoarthritis Index WOMAC as an outcome measure methods This is a prospective, single-arm, interventional clinical study conducted at the Department of Repertory and case taking, AM Shaikh Homoeopathic Medical College Hospital p g and research centre belagavi A total of 55 postmenopausal women aged 45–65 years diagnosed with primary knee osteoarthritis will be enrolled after informed consent Each participant will undergo detailed case taking and repertorization using the Rheumatic Remedies Repertory Individualized homoeopathic medicines will be prescribed in suitable potencies 30C or 200C or 1M and followed up monthly for 6 months No comparator or placebo arm will be used outcome Improved The Western Ontario and McMaster Universities Osteoarthritis Index score below 60 indicates the improvement in the case after intervention Not improved The Western Ontario and McMaster Universities Osteoarthritis Index score above 60 indicates not improvement in the case after intervention analysis Pre- and post-intervention WOMAC scores will be analyzed using paired t-test or non-parametric equivalent, with p < 0.05 considered statistically significant. results: The study is expected to demonstrate measurable improvement in WOMAC scores, reflecting reduction in pain, stiffness, and improved joint function, thereby supporting the role of individualized homoeopathic medicines selected via Rheumatic Remedies Repertory in managing primary knee osteoarthritis among postmenopausal women |