Skip to main content
Clinical Trials/CTRI/2024/03/064632
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
The Calcutta Homoeopathic Medical College and Hospital

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

Similar Trials