Health Condition 1: M170- Bilateral primary osteoarthritis of knee Health Condition 2: F411- Generalized anxiety disorder Health Condition 3: F321- Major depressive disorder, singleepisode, moderate
Conditions
Interventions
Intervention1: Individualized homoeopathic medicines in centesimal potencies plus concomitant care: Intervention is planned as
administering indicated
homoeopathic remedy in
centesimal potencies, as
d
duration of therapy: 3 months
Control Intervention1: Identical-looking placebos and
concomitant care: This arm will receive placebo,
indistinguishable in appearance from verum. Each dose of placebo sh
dosage and repetition depending upon the individual requirement of the cases. All sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. All the enrolled patients
Sponsors
The Calcutta Homoeopathic Medical College and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Diagnosed knee osteoarthritis (ICD-11 code FAO1) as per American College of Rheumatology (ACR) clinical/radiographic classification criteria45 (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. 2. Age: 50-70 years. 3. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for depression (five or more symptoms out of nine for 2 weeks including at least one of these: depressed mood and loss of interest or pleasure) and/ or anxiety (more than three symptoms out of six including excessive anxiety and worry occurring at least six months, about number of events or activities) as per American Psychiatric Association (APA) 4. DASS-21 depression score: 10-27 (mild and moderate). 5. Patients of either sex including transgenders. 6. 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 providing written informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Patients not willing to give written consent voluntarily. 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. DASS-21 depression score: 0-9 (normal) and above 28 (extremely severe). 7. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life threatening illness affecting quality of life 8. Pregnancy, puerperium and lactation. 9. Vulnerable population – Unconscious, non-ambulatory, too ill for consultation, differently abled, terminally ill, or critically ill patients, mentally disabled people. 10. Substance abuse and /or dependence 11. Self-reported immune-compromised state, and 12. Undergoing homoeopathic treatment for any chronic disease within last 6 months 13. Simultaneous participation in any other clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DASS-21 (Depression, anxiety, and Stress Scale 21) depression subscaleTimepoint: Every month, up to 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| DASS-21 (Depression, anxiety, and Stress Scale 21) anxiety and stress subscalesTimepoint: Every month, up to 3 months;KOOS (Knee Injury and Osteoarthritis Outcome Score)Timepoint: Every month, up to 3 months;MYMOP-2 (The Measure Yourself Medical Outcome Profile revised version)Timepoint: Every month, up to 3 months | — |
Countries
India
Contacts
Public ContactRajat Chattopadhyay
The Calcutta Homoeopathic Medical College and Hospital
Outcome results
None listed