CTRI/2024/03/064632
Not yet recruiting
Phase 2
Evaluating the efficacy of individualized homoeopathic medicines in reducing depression, anxiety, and stress in adults with osteoarthritis of knee: a double-blind, randomized, placebo-controlled trial - NI
The Calcutta Homoeopathic Medical College and Hospital0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- The Calcutta Homoeopathic Medical College and Hospital
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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)
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.
Outcomes
Primary Outcomes
Not specified
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