Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee

A Six-month, Multi Center, Randomizied, Double Blind, Parallel-group,Placebo Controlled Study to Evaluate Efficacy and Safety of Imotun Capsule in Osteoarthritis of the Knee

Efficacy and safety of Imotun capsule in osteoarthritis of the knee

A six-month, multi center, randomizied, double blind, parallel-group,placebo controlled study to evaluate efficacy and safety of Imotun capsule in osteoarthritis of the knee

Inclusion Criteria:

• Agreement with written informed consent and 40 years of age and older
• Patients with more than 63months history of OA of knee according to ACR criteria
• Radiographic evidence of Kellgren & Lawrence grade II to III OA of the knee
• The 100mm Pain VAS is over 40mm
• The Lequensne's index is over 5

Exclusion Criteria:

• Treatment with SYSADOA within 3 months
• History of joint surgery within 5 years or Arthroscopic surgery within 1year
• Intra-articular injections within 3 months
• Treatment with NASIDs within 7 days
• Any history of adverse reaction to the study drugs
• clinically significant hepatic, renal, cardiovascular diseases
• Patients with gastrointestinal ulcers or bleeding disorders
• Pregnant women, nursing mothers or Fertile women who not practice contraception with appropriate methods
• History of drug abuse or alcoholism
• Patients on any other clinical trial or experimental treatment in the past 4 weeks
• An impossible one who participates in clinical trial by investigator's decision