Health Condition 1: M172- Bilateral post-traumatic osteoarthritis of knee
Conditions
Interventions
Intervention1: Individualized Homoeopathic medicines in centesimal potencies with concomitant care: â?¢Experimental arm: Intervention is planned considering causation (trauma) rubric in totality and a
dosage and repetition depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm.
â?¢Comparator arm:This arm will r
dosage and repetition depending upon the individual requirement of the cases. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Duration of therapy: 3 months with
Sponsors
The Calcutta Homoeopathic Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 30-70 years 2. Patients of either sex including transgenders. 3. Diagnosed knee osteoarthritis as per American College of Rheumatology (ACR) clinical or radiographic classification criteria (sensitivity 91%; specificity 86%) - history of trauma over knee, knee pain, stiffness less than 30 min, and crepitus on knee motion, osteophytes on knee x-ray 4. Patients already undergoing regular oral or topical analgesics or NSAID therapy for painful episodes of osteoarthritis, provided the medications are stopped completely at least 2 weeks prior study entry 5. Literate patients; able to read Hindi and/or English 6. Providing written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Severe degeneration of knee joint with marked joint narrowing, varus or valgus deformity of knee ( >12°), evidenced by imaging or other evidences and requiring surgical intervention 2. Self-reported joint disorders other than osteoarthritis (e.g., inflammatory joint disease, specific arthropathy, hyperuricemia and/or gout, severe axis deviations or instabilities, joint or skin infections, joint prostheses of the lower limbs) 3. Intra-articular injections within 2 weeks before study entry 4. Transplanted knees 5. Recent significant knee surgery within last 6 months 6. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life 7. Pregnancy, puerperium and lactation 8. Vulnerable population â?? unconscious, non-ambulatory, too ill for consultation, differently abled, terminally ill or critically ill patients, mentally disabled people 9. Substance abuse and/or dependence 10. Self-reported immune-compromised state, and 11. Undergoing homeopathic treatment for any chronic disease within last 6 months 12. Simultaneous participation in any other clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS)Timepoint: At baseline, and every month, up to 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| EQ-5D-5L questionnaireTimepoint: At baseline, and every month, up to 3 months;EQ-5D-5L VASTimepoint: At baseline, and every month, up to 3 months | — |
Countries
India
Contacts
Public ContactRajat Chattopadhyay
The Calcutta Homoeopathic Medical College and Hospital
Outcome results
None listed