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Therapeutic potential of Sulphasalazine to reduce ultrasonography detected synovitis.

A single-centric, double-blinded randomized parallel group non-inferiority study to the therapeutic potential of Sulfasalazine in alleviating ultrasonography detected synovitis in patients with osteoarthrities knee - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/062916
Enrollment
54
Registered
2024-02-20
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: M179- Osteoarthritis of knee, unspecified

Interventions

Intervention1: Sulphasalazine Duloxetine: Tab Sulphasalazine 30 mg/kg/day and Tab Duloxetine 40 mg/day in divided doses for 12 weeks. Control Intervention1: Multivitamin Duloxetine: Tab Multivitamin

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patient in chronic knee pain(pain more than 3 months) diagnosed as OA Knee of either grade I,II or III in accordance to kellgren Lawrence(KL) grading system 45 TO 80 years age, having ultrasound features of synovial hypertrophy will be included in our study.

Exclusion criteria

Exclusion criteria: Patients coexistent local or systemic inflammatory processes, OA knee grade (IV) history of inflammatory arthropathies or knee joint surgery, patients with hypersensitivity to sulfasalazine, its metabolite, sulfonamides, salicylates, or any component of the formulation, intestinal or urinary obstruction, and porphyria, will also be excluded from the study.

Design outcomes

Primary

MeasureTime frame
The primary endpoints of the study will be effusion-synovitis volume and VAS painTimepoint: 6 and 12 weeks

Secondary

MeasureTime frame
1) Total dosage of analgesic requirement. 2) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Timepoint: 6 and 12 weeks

Countries

India

Contacts

Public ContactGautam Das

Daradia the pain clinic

gdas2310@gmail.com09163357246

Outcome results

None listed

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