Clinical Evaluation of TLPL/AY/03/2008 in Osteoarthritis of Knee Joint

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 32

Inclusion Criteria

•Males and Females, age group 40-70 years

•Symptoms of osteoarthritis in one or both knee joints for a minimum of six months and maximum for five years

•History of knee pain due to osteoarthritis requiring the use of NSAIDs, Acetaminophen, or another analgesic agent on a regular basis ( > three days per week) for at least six months before the screening visit

•OA confirmed by radiographs and diagnosed according to ACR diagnostic Criteria for the osteoarthritis of the knee(s)

•Subjects may take tab paracetamol (<= 2g/day) for breakthrough pain

•Subjects not having knee joint deformity

•Subjects with pain VAS > 40 mm on weight bearing activities

Exclusion Criteria

• RA, gout inflammatory arthritis Pagets disease of bone chronic pain syndrome fibromyalgia or another major joint disease

•History of surgery including arthroscopy or major trauma to the study joint in the previous six months before the screening visit

•Subjects requiring knee arthroplasty within 6 months of screening or anticipating any need for a surgical procedure on the index joint during the study

•Signs of clinically important active inflammation of the study knee joint including redness warmth and/or a large bulging effusion with the loss of normal contour at the screening and/or baseline visits

•Use of systemic corticosteroids within 2 months of screening or intra-articular viscosupplementation within the past 3 months

•Use of any other investigational drug within 1 month prior to randomization

•Subjects having diabetes mellitus tuberculosis HIV Ischemic Heart Disease

•Known other major medical or surgical disease

•Pregnancy and Lactation

•Known hypersensitivity to ingredients used in study drug

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Average Change in Knee joint(s) pain on Visual Analogue Scale (VAS) <br/ ><br> <br/ ><br>2. Average change in WOMAC Osteoarthritis IndexTimepoint: Day 0, Day 30, Day 60, Day, 90, Day 120, Day 150 and Day 180

Secondary Outcome Measures

Name	Time	Method
1.Average Change in the Swelling of Knee Joint(s) <br/ ><br>2.Average change in score of global assessment for overall improvement by the Physician and by Patient <br/ ><br>3.Assessment of tolerability of the trial drug in patient with osteoarthritis of the Knees and Laboratory parametersTimepoint: Day 0 Day 180