Overview
To Evaluate the Safety of 'Shinbaro Capsule'in Patients With Osteoarthritis
Status:
Completed
Completed
Trial end date:
2013-06-01
2013-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Green Cross Corporation
Criteria
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