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Clinical Trials/CTRI/2013/05/003618
CTRI/2013/05/003618
Recruiting
Phase 4

A comparative study to evaluate efficacy,safety and cost effectiveness between Tramadol and Diclofenac with and without proton pump inhibitor in patients with knee osteoarthritis.

DrMehwishmajeed0 sites94 target enrollmentTBD
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Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
DrMehwishmajeed
Enrollment
94
Status
Recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

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

Investigators

Sponsor
DrMehwishmajeed

Eligibility Criteria

Inclusion Criteria

  • •1\.Patientsâ?? aged 45 years or older of either sex.
  • •2\.Patients consulting for non\-traumatic knee pain/primary symptomatic knee OA.
  • •3\.Complying to the clinical American College of Rheumatology (ACR) criteria for osteoarthritis of the knee.
  • •4\.A score of 3 or more on the pain severity scale (0\-10 scale).
  • •5\.Patient willing to provide informed written consent

Exclusion Criteria

  • •. Contra\-indication for NSAID or Paracetamol use (these are: Gastrointestinal bleedings in history or active peptic ulcer, serious liver or kidney disease (glomerular filtration less than 30 ml/min),
  • •2\. An arthroplasty or osteotomy of the knee.
  • •3\. Surgery or major trauma of the affected joint within the previous 6 months
  • •4\.Pregnancy and lactating women.
  • •5\.Patients who were treated with corticosteroid and hyaluronic injection to the target joint within two months prior to the study medication administration.
  • •6\. Patient having osteoarthritisfor more than 5 years.
  • •7\.Patients with Rheumatoid arthritis, Ankylosing spondylitis, Active gout or active pseudo\-gout.
  • •8\.Patients advised physiotherapy

Outcomes

Primary Outcomes

Not specified

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