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 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月1日

试验速览

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•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.

•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.

发起方

The Calcutta Homoeopathic Medical College and Hospital