Osteoarthritis
Conditions
Keywords
Osteoarthritis, Shinbaro, Herbal drug
Brief summary
This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.
Interventions
DRUGShinbaro Capsule
600mg twice a day (b.i.d) oral herbal medicine
Sponsors
Green Cross Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of subjects with gastrointestinal adverse events | Baseline through 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| percentage of subjects who withdrew due to GI AEs | baseline through week 24 |
| Frequency of AEs | baseline throgh week 24 |
| percentage of subjects with perforation, ulcer, bleeding | baseline throgh week 24 |
| KKS (Korean Knee Score) change from baseline | 24 weeks |
| 100mm pain VAS on walking | 24 weeks |
| WOMAC change from baseline | 24 weeks |
Countries
South Korea
Outcome results
None listed