To Evaluate the Safety of 'Shinbaro Capsule'in Patients With Osteoarthritis

A 24 Weeks, Multi-centers, Single Arm Phase IV Study to Evaluate the Safety of 'Shinbaro Capsule' Compared With Historical Data of 'Celebrex Capsule' in Patients With Osteoarthritis

This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.

Inclusion Criteria:

• Minimum 19 years old
• Kellgren stage I ~ III by ACR criteria
• Stable osteoarthritis during 3 months
• Be able to perform WOMAC and KKS
• Written consent form voluntarily

Exclusion Criteria:

• Disease of orthopaedic surgical that could affect to evaluate the efficacy
• Medication of continuous corticosteroid by oral or articular cavity within 12 weeks
• Medication of constantly (more than 1 week) antipsychotic drug or narcotic analgesics within four weeks
• Medical history of hypersensitivity reaction against Herbal drug
• Genetic factors as galactose intolerance, lapplactase deficiency or glucose-galactose malabsorption, etc.
• Occurrence of OA caused by the injury
• Diagnosed with psychical disorder, and taking medication
• Diagnosed with active peptic ulcers, gastrointestinal bleeding, inflammatory bowel disease, severe liver dysfunction, severe renal dysfunction, congestive heart failure, clinically significant ischemic heart disease, peripheral arterial disease, or cerebrovascular diseases
• Diagnosed with esophagus and gastrointestinal ulceration within 1 year, or treated it
• Abnormal bleeding (abnormal of platelet or blood coagulation factor, etc.)
• Positive in fecal occult blood test
• Gastrointestinal tract surgery except appendectomy
• Serum creatinine, ALT, AST, total bilirubin over UNL x 1.5 at screening test
• Participation in another clinical trials within 4 weeks
• Not consent about using effectual contraception method during trial
• Pregnant or lactating woman
• Medical history of malignant tumor within 5 years
• Investigator's judgment