Non-Bleeding Peptic Ulcers Clinical Trial
Official title:
DLBS2411 Treatment for Ulcer Healing in Non-Bleeding Peptic Ulcers
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.
A total of 140 subjects will be allocated into 2 groups of treatment; each group will consist
of 70 subjects with the treatment regimens:
Treatment I : 2 capsules of Omeprazole 20 mg, once daily and 1 placebo caplet of DLBS2411,
twice daily Treatment II : 1 caplet of DLBS2411 250 mg, twice daily and 2 placebo capsules of
omeprazole, once daily
DLBS2411 will be administered twice daily at least 30 minutes before morning and evening
meals, while omeprazole, once daily before morning meals, for 8 weeks of study period.
The eligible subjects will receive either study medication (Treatment 1 or Treatment 2), for
8 weeks of treatment; and will be instructed to come to the clinic every 4-week interval
throughout the study period.
Subjects will be evaluated for treatment efficacy at baseline and at interval of 4 weeks over
the 8-week course of therapy.
The safety profile of study medication other than vital signs and adverse event will be
measured at baseline and end of study. Vital signs and adverse event will be measured at
baseline and every follow-up visit including end of study.
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