Efficacy and Safety of DLBS2411 in the Management of GERD
Status:
Terminated
Trial end date:
2020-09-09
Target enrollment:
Participant gender:
Summary
This is a 2-arm, prospective, double-blind double-dummy, randomized-controlled study
comparing DLBS2411 at a dose of 250 mg twice daily with omeprazole at a dose of 20 mg twice
daily, given before morning and evening meals, for an 8-week course of therapy. Subjects
should avoid taking meals 2-3 hours before bedtime.
The bioactive fraction of DLBS2411 has been proved at cellular and genetic levels to have an
antiulcer effect through both suppressing the gastric acidity and enhancing gastric mucosal
protection. The anti-secretory effect of DLBS2411 is exerted through the inhibition of H+/K+
ATPase 'pump' as well as down-regulation of the H+/K+ ATPase gene expression, thus
suppressing gastric acid secretion; while its cytoprotective defense mechanism works through
the promotion of cyclooxygenase-2 (COX-2) derived prostaglandin (PgE2) synthesis, thus
promoting gastrointestinal submucosal blood-flow, stimulating secretion of gastric-epithelial
mucous and bicarbonate; anti-oxidative activity; and endothelial-nitric oxide (NO) formation.
Recent study of DLBS2411 which was conducted in healthy volunteers, demonstrated the
effective role and safety of DLBS2411 in suppressing intragastric acidity. Having such
mechanisms of action, DLBS2411 is hypothesized to benefit patients with gastric acid
disorders such as in gastroesophageal reflux disease (GERD).