An Open Label, Prospective Clinical Study to Evaluate The Efficacy and Safety of TLPL/AY/03/2008 in Patients suffering from Osteoarthritis of the Knee(s) - NI

Tulip Lab Private Limited0 个研究点目标入组 32 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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

发起方

Tulip Lab Private Limited