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

Green Cross Corporation

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis

Treatments

Drug: Shinbaro Capsule

Study type

Interventional

Funder types

Industry

Identifiers

GCSB_P4

Details and patient eligibility

About

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

Enrollment

761 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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