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

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

Official Title
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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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Shinbaro Capsule


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shinbaro<br> | Drug: Shinbaro Capsule<br>* 600mg twice a day (b.i.d) oral herbal medicine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with gastrointestinal adverse events |  | Baseline through 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of subjects with perforation, ulcer, bleeding |  | baseline throgh week 24 | 
| percentage of subjects who withdrew due to GI AEs |  | baseline through week 24 | 
| Frequency of AEs |  | baseline throgh week 24 | 
| WOMAC change from baseline |  | 24 weeks | 
| KKS (Korean Knee Score) change from baseline |  | 24 weeks | 
| 100mm pain VAS on walking |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Shinbaro, Herbal drug