The purpose of this study is to evaluate the efficacy of eupatilin on the prevention of gastroenteropathy in patients with NSAIDs and low dose steroid by comparing with rebamipide.
After being informed of the study and potential risks, all patients giving written informed consents will undergo a 1-week screening period to determine eligibility for study entry. During screening period, patients will undergo fecal calprotectin test, upper endoscopy and submit symptom diary. At week 0, subjects who meet the eligibility criteria will be randomized in a open labeled manner in 1:1 ratio to eupatilin (90mg twice daily-test group, 25 patients) or rebamipide (100mg three times daily-control group paients) for 8 weeks. At week 8, subjects undergo fecal calprotectin test, upper endoscopy and submit symptom diary.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
take eupatilin to prevent NSAID induced gastroenteropathy
take rebamipide to prevent NSAID induced gastroenteropathy
Percentage of patients with gastric damage
Percentage of patients with endoscopic Modified Lanza Score \>3
Time frame: evaluated at day 56
Change of gastric erosion number
Change of gastric erosion number at day 56 compared with that at day 0
Time frame: evaluated at day 0 and day 56
Change of Modified Lanza Score
Change of Modified Lanza Score at day 56 compared with that at day 0
Time frame: evaluated at 0 day and day 56
Change of duodenal erosion number
Change of duodenal erosion number at day 56 compared with that at day 0
Time frame: evaluated at day 0 and day 56
Gastrointestinal symptom
Gastrointestinal symptom change using survey at day 56 compared with that at day 0
Time frame: evaluated at day 0 and day 56
Fecal calprotectin
Fecal calprotectin level change at visit 3 compared with visit 0
Time frame: evaluated at day 0 and day 56
Antioxidant gene expression
Antioxidant gene expression change at day 56 compared with that at day 0
Time frame: evaluated at day 0 and day 56
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