A clinical trial to study of Oxaceprol capsule with Diclofenac tablet for the treatment of the patients with osteoarthritis.

A phase III, multicentric, single blind, randomized, comparative study to assess the efficacy and safety of Oxaceprol capsule with Diclofenac tablet in patients with osteoarthritis.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000798

Enrollment

200

Registered

2009-10-15

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- Osteoarthritis

Interventions

Intervention1: Oxaceprol Capsule: Oxaceprol (200 mg) two capsules thrice a day Control Intervention1: Diclofenac Tablet: Diclofenac (50 mg) one tablet thrice a day

Eligibility

Inclusion criteria

Inclusion criteria: ? Age >18 Yrs. ? Patients with h/o symptoms & sign of Osteoarthritis. ? Age >18 Yrs. ? Patients with h/o symptoms & sign of Osteoarthritis. ? Normal Hematology, RFT, LFT ? Patients willing to come to OPD for follow up. ? Willing to give written informed consent Normal Hematology, RFT, LFT ? Patients willing to come to OPD for follow up. ? Willing to give written informed consent

Exclusion criteria

Exclusion criteria: ? Hypersensitive to Oxaceprol and Diclofenac ? Patients with h/o renal impairment, bleeding tendencies, cirrhosis and esophageal varices. ? Patients who have participated in a drug study in ? Hypersensitive to Oxaceprol and Diclofenac ? Patients with h/o renal impairment, bleeding tendencies, cirrhosis and esophageal varices. ? Patients who have participated in a drug study in the past 6 months. ? Corticosteroid use. ? Significant cognitive impairment. the past 6 months. ? Corticosteroid use. ? Significant cognitive impairment.

Design outcomes

Primary

Measure	Time frame
Efficacy will be assessed by changes in the following variables: 1 Pain (Visual Analog Scale) 2 Stiffness 3 QOL Questionnaires (WOMAC INDEX) Timepoint: screening, enrollment, weekly up to 3 weeks	—

Secondary

Measure	Time frame
Secondary outcome Based on the following variables. 1. Adverse events 2. Rescue medication 3. Change in the pathological parameters Timepoint: second & Third week	—

Countries

India

Contacts

Public ContactDrAlok Chaturvedi

alokchaturvedi@lupinpharma.com02266402200

Outcome results

None listed

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