This study investigates if Shinbaro capsule has a lower incident of gastrointestinal events than celecoxib in subjects with osteoarthritis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
761
600mg twice a day (b.i.d) oral herbal medicine
Kyungpook national university hospital
Daegu, Kyungpook, South Korea
BundangCha Hospital
Bundang, South Korea
Percentage of subjects with gastrointestinal adverse events
Time frame: Baseline through 24 weeks
percentage of subjects with perforation, ulcer, bleeding
Time frame: baseline throgh week 24
percentage of subjects who withdrew due to GI AEs
Time frame: baseline through week 24
Frequency of AEs
Time frame: baseline throgh week 24
WOMAC change from baseline
Time frame: 24 weeks
KKS (Korean Knee Score) change from baseline
Time frame: 24 weeks
100mm pain VAS on walking
Time frame: 24 weeks
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...and 8 more locations