A study to evaluate cost effectiveness and safety of pain killers with and without acid reducing drugs in patients having pain in knee.

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.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/05/003618

Enrollment

Registered

2013-05-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- knee osteoartharitis

Interventions

Intervention1: Tramadol + Omeprazole , Diclofenac+ Famotidine , Diclofenac +Omeprazole : Tramadol (200mg SR OD)+PPI (Omeprazole 20mg)for 2 wks orally, Diclofenac(100mg SR OD)+ H2 blocker( Famotidi

Eligibility

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
1 KOOS questionnaire:The Knee injury and Osteoarthritis Outcome Score 2.Efficacy by VAS(Visual analogue score) questionnaire 3.Cost effective analysis between Tramadol and diclofenac 4.adverse effects of Tramadol and DiclofenacTimepoint: 2 and 4 wks	—

Secondary

Measure	Time frame
1. relation between demographic profile of patients and knee osteoarthritis 2.The quality of life of osteoarthritis patients by KOOS 4. To compare cost effectiveness of Diclofenac with H2 blocker or PPI Timepoint: 2 and 4 wks	—

Countries

India

Contacts

Public ContactDrMehwishmajeed

B.V.U.Medical College, Dhankawadi, Pune

karandikar_yogita@yahoo.com9922747908

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026