A clinical trial to study of Oxaceprol capsule with Diclofenac tablet for the treatment of the patients with osteoarthritis.
- Conditions
- Health Condition 1: null- Osteoarthritis
- Registration Number
- CTRI/2009/091/000798
- Lead Sponsor
- upin Ltd Mumbai
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
?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
?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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy will be assessed by changes in the following variables: <br/ ><br>1 Pain (Visual Analog Scale) <br/ ><br>2 Stiffness <br/ ><br>3 QOL Questionnaires (WOMAC INDEX) <br/ ><br>Timepoint: screening, enrollment, weekly up to 3 weeks
- Secondary Outcome Measures
Name Time Method Secondary outcome Based on the following variables. <br/ ><br>1.Adverse events <br/ ><br>2.Rescue medication <br/ ><br>3.Change in the pathological parameters <br/ ><br>Timepoint: second & Third week