Homoeopathic treatment for depression and knee pai

Phase 2

Conditions: Health Condition 1: M170- Bilateral primary osteoarthritis of kneeHealth Condition 2: F411- Generalized anxiety disorderHealth Condition 3: F321- Major depressive disorder, singleepisode, moderate

Registration Number: CTRI/2024/03/064632

Lead Sponsor: The Calcutta Homoeopathic Medical College and Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DASS-21 (Depression, anxiety, and Stress Scale 21) depression subscaleTimepoint: Every month, up to 3 months

Secondary Outcome Measures

Name	Time	Method
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