Effect of pain relieving action of piroxicam in patients with osteoarthritis of knee due to minor modification in gene degrading piroxicam

Phase 4

• Conditions: Health Condition 1: M170- Bilateral primary osteoarthritis of kneeHealth Condition 2: null- Osteoarthritis of knee

• Registration Number: CTRI/2018/05/013673
• Lead Sponsor: Sri Devaraj Urs Academy of Higher Education and Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients of either gender, aged between 40-70years

2.Body mass index (BMI) of 25-30

3.Patients with symptomatic idiopathic OA

4.Knee osteoarthritis of mild to moderate type

5.Radiological evidence of OA of involved joint

6.Morning stiffness of less than 30 minutes duration with crepitus on motion

7.Patients who were on NSAIDs including piroxicam and should have discontinued the drug for a period of two weeks before recruitment

Exclusion Criteria

1.Patients with history of surgery or acute trauma to the knee joint in the past 6months

2.Patients with history of peptic ulcer, gastrointestinal bleeding, psychiatric illness and bronchial asthma

3.Patients with history of acute inflammatory arthritis, pseudo gout or severe osteoporosis

4.Patients with history of allergy to study drug

5.Patients with deranged hepatic and renal parameters

6.Pregnant and lactating women

7.Patients who use other measures for pain relief like massage, acupuncture, hydrotherapy, homeopathy, chiropractic manipulation, transcutaneous electrical nerve stimulation, use of knee braces, shoe wedges, application of creams containing capsaicin, self medication with analgesics and nutritional supplements like glucosamine and chondroitin sulfate during the past 4 weeks and study period.

8.Patients with uncontrolled diabetes mellitus and hypertension

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlate the CYP2C9 gene polymorphisms with reduction in VAS (Visual Analogue Scale),WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)score and <br/ ><br>Patientâ??s satisfaction score <br/ ><br>Timepoint: <br/ ><br>24 months

Secondary Outcome Measures

Name	Time	Method
VAS, WOMAC, Patients satisfaction score, Adverse effects using WHO causality assessment scaleTimepoint: 2, 4, 6 weeks, 3rd month, 6th month and 1 year after starting the drug