DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers
Status:
Terminated
Trial end date:
2019-03-01
Target enrollment:
Participant gender:
Summary
This is a 2-arm, prospective, double-blind, double-dummy, randomized-controlled study using
DLBS2411 at a dose of 250 mg twice daily (before morning and evening meals), or omeprazole at
a dose of 40 mg once daily (before morning meal), for an 8-week course of therapy, for the
treatment of patients with any non-bleeding peptic ulcers.
DLBS2411 is a bioactive fraction of an Indonesian native herbal, Cinnamomum burmanii, locally
known as kayu manis have been proven 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 gastro-protective defense mechanism works through the
promotion of COX-2 derived prostaglandin (PgE2) synthesis, stimulating gastric-epithelial
mucous and bicarbonate secretion; anti-oxidative activity; and endothelial-nitric oxide (NO)
formation.
Recent study of DLBS2411 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 in peptic ulcers.