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Testing How Safe and Effective Bonivia OA Tablets Are for Treating Knee Osteoarthritis: A Clinical Study

EVALUATION OF THE EFFICACY AND SAFETY OF TABLET BONIVIA OA IN KNEE OSTEOARTHRITIS: A RANDOMIZED CONTROLLED CLINICAL STUDY - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095056
Enrollment
60
Registered
2025-09-18
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: M17- Osteoarthritis of knee

Interventions

None listed

Sponsors

SAVA Healthcare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age greater than or equal to 50 Years Diagnosed with primary knee OA as per ACR criteria ACR Functional Status Class I, II, or III Willing to give informed consent Diagnostic criteria as per ACR (American College of Rhuematology) Knee pain plus any three of the following: Age greater than or equal to 50 years Morning stiffness less than 30 minutes Crepitus Bony tenderness Bony enlargement No palpable warmth

Exclusion criteria

Exclusion criteria: Radiographic Grade greater than or equal to 3 OA (Kellgren-Lawrence classification) Significant knee trauma or arthroscopy in past 1 year History of knee joint replacement BMI greater than or equal to 30 kg per m Intra-articular corticosteroids or hyaluronic acid in the last month Use of corticosteroids in last month History of rheumatoid arthritis, psoriatic arthritis, or any inflammatory arthritis Liver enzymes greater than 3 normal, or serum creatinine greater than 1.2 mg% Active or prior malignancy Known hypersensitivity to study drugs Any condition that may affect safety or compliance (as per the investigator s opinion)

Design outcomes

Primary

MeasureTime frame
Improvement in Clinical Symptoms of Knee OA Improvement in WOMAC Index Score Improvement in Numeric Pain Rating Scale (NPRS) Improvement in inflammatory and degenerative markers Improvement in health-related quality of life (SF-12) Reduction in Rescue Analgesic useTimepoint: Follow up on Days 30th, 60th, 90th, 120th

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr MADHAVI MAHAJAN

BVDU COLLEGE OF AYURVED AND HOSPITAL,

madhavi.mahajan@bharatividyapeeth.edu9860124248

Outcome results

None listed

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