| CTRI Number |
CTRI/2025/10/095631 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of constitutional homeopathic medicine in osteoarthritis |
|
Scientific Title of Study
|
A prospective study to ascertain the effectiveness of constitutional homoeopathic medicines in cases of osteoarthritis in the age group of 35 to 65 years using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanani Manas Bhavikkumar |
| Designation |
PG student |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
203 Shrinathji Apartment Hari Nagar 6 Bhid Bhanjan Society near Kailash Village Rajkot 360005
Room no 101 Medicine OPD Gondal Road near Makkam Chowk Udhyog Nagar Colony Bhakti Nagar Rajkot Gujarat 360002
Rajkot
GUJARAT
360005
India |
| Phone |
9773023103 |
| Fax |
|
| Email |
kananimanas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Hitarth Mehta |
| Designation |
B.H.M.S. M.D. (Homoeopathy) |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
A 32 Oscar Residency 150 Ft Ring Road behind Sterling Hospital Rajkot
Room no 101 Medicine OPD Gondal Road near Makkam Chowk Udhyog Nagar Colony Bhakti Nagar Rajkot Gujarat 360002
Rajkot
GUJARAT
360007
India |
| Phone |
9825340073 |
| Fax |
|
| Email |
hitarthmehtarhmc@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Kanani Manas Bhavikkumar |
| Designation |
PG student |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
203 Shrinathji Apartment Hari Nagar 6 Bhid Bhanjan Society near Kailash Village Rajkot
Room no 101 Medicine OPD Gondal Road near Makkam Chowk Udhyog Nagar Colony Bhakti Nagar Rajkot Gujarat 360002
Rajkot
GUJARAT
360005
India |
| Phone |
9773023103 |
| Fax |
|
| Email |
kananimanas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College Room no 101 Medicine OPD Gondal Road near Makkam Chowk Udhyog Nagar Colony Bhakti Nagar Rajkot Gujarat India 360002 |
|
|
Primary Sponsor
|
| Name |
Sainath Hospital |
| Address |
Room no 101 Medicine OPD Gondal Road near Makkam Chowk Udhyog Nagar Colony Bhakti Nagar Rajkot Gujarat 360002 |
| 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 Manas Kanani |
Sainath Hospital |
Room no 101 Medicine OPD Gondal Road near Makkam Chowk Udhyog Nagar Colony Bhakti Nagar Rajkot Gujarat 360002
Rajkot
GUJARAT |
9773023103
kananimanas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH - RAJKOT HOMOEOPATHIC MEDICAL COLLEGE [RHMC] , PARUL UNIVERSITY , GUJARAT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M199||Osteoarthritis, unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A prospective study to ascertain the effectiveness of constitutional homoeopathic medicines in cases of osteoarthritis in the age group of 35 to 65 years using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale |
Intervention Name:Constitutional Homoeopathic MedicinesType of Intervention:Drug – HomoeopathicDetails of Intervention:Individualized constitutional homoeopathic medicines will be prescribed to participants based on detailed case-taking in accordance with classical homoeopathic principles. The remedy selection will be made after considering the totality of symptoms, general symptoms, mental state, past history, family history, and miasmatic background. Medicines will be sourced from a GMP-certified homoeopathic pharmacy and administered in centesimal potencies (such as 30C, 200C, or 1M) based on the susceptibility of the patient and the judgment of the treating physician. Dosage and repetition will follow standard homoeopathic protocols.Route of Administration:OralFrequency and Duration:Medicine will be administered as per individualized requirement (e.g., once daily, once weekly, or as a single dose), with follow-up at regular intervals over a period of 3 to 6 months. Adjustments in potency or repetition will be made according to the clinical response assessed using the WOMAC scale and homoeopathic follow-up criteria. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: Patients aged 35-65 years with a diagnosis of osteoarthritis (OA) based on clinical and radiological findings.
2. OA Diagnosis: Patients with a confirmed diagnosis of OA from radiological findings.
3. OA Severity: Patients with mild to moderate OA, as defined by the Kellgren-Lawrence grading system or the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
4. Homoeopathic Treatment: Patients willing to receive homoeopathic treatment as part of the study.
|
|
| ExclusionCriteria |
| Details |
1. Severe OA: Patients with severe OA, as defined by the Kellgren-Lawrence grading system or WOMAC.
2. Other Rheumatic Diseases: Patients with other rheumatic diseases, such as rheumatoid arthritis, psoriatic arthritis, or gout.
3. Recent Injections or Surgery: Patients who have received corticosteroid injections or undergone surgery on the affected joint within the past 6 months.
4. Medications: Patients taking medications that may interfere with the study outcomes, such as: - Corticosteroids , Immunosuppressants , Opioids
5. Pregnancy or Lactation: Pregnant or lactating women.
6. Allergies or Sensitivities: Patients with known allergies or sensitivities to homoeopathic remedies.
7. Concurrent Treatment: Patients receiving concurrent treatment for OA, such as: - Acupuncture
- Other alternative therapies
8. Cognitive or Psychiatric Impairment: Patients with significant cognitive or psychiatric impairment that may affect their ability to participate in the study.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) total score from baseline to follow-up.
WOMAC measures pain, stiffness, and physical function — internationally validated, widely used in OA research. |
Baseline 15 days , 30 days , 45 days post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in WOMAC domain scores (pain, stiffness, function) at 4, 8, and 12 weeks.
Change in analgesic/NSAID requirement.
Safety and tolerability of homoeopathic medicines. |
WOMAC Domain Scores (Pain, Stiffness, Physical Function)
Time points: Baseline, 4 weeks, 8 weeks, 12 weeks (primary endpoint), and optionally 24 weeks (if you want longer-term follow-up).
Use of Concomitant Analgesics / NSAIDs (frequency and dose reduction compared to baseline)
Time points: Recorded at each follow-up visit (4, 8, 12 weeks).
Adverse Events and Tolerability
Time points: Monitored continuously; documented at every visit (4, 8, 12 weeks).
Quality of Life (optional, e.g., SF-36 or EQ-5D if you plan to include it)
Time points: Baseline and 12 weeks |
|
|
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)
|
14/10/2025 |
| 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="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
|
Osteoarthritis (OA) is a common degenerative joint disorder leading to chronic pain, stiffness, and functional disability. Conventional treatments mainly provide symptomatic relief and may have limitations due to side effects or long-term unsustainability. Homoeopathy, as a holistic system of medicine, emphasizes individualized constitutional remedies and has been widely used for musculoskeletal conditions, though systematic evidence remains limited.
This prospective, open-label, single-arm academic study will evaluate the effectiveness of constitutional homoeopathic medicines in patients with mild to moderate osteoarthritis (age 35–65 years), using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale as the primary outcome measure.
A total of 50 patients diagnosed with OA (radiological confirmation, Kellgren-Lawrence criteria) will be enrolled from OPD/IPD and peripheral camps of Sainath Homoeopathic Hospital, Rajkot. Patients will receive individualized constitutional homoeopathic medicines based on detailed case taking. Follow-up will be every 15 days for 12 weeks.
Primary Outcome: Change in WOMAC total score (pain, stiffness, physical function) from baseline to 12 weeks.
Secondary Outcomes: Adverse events, quality of life, patient satisfaction.
This study aims to provide evidence on the role of constitutional homoeopathy in OA management, potentially contributing to integrative approaches for chronic musculoskeletal disorders.
|