NCT05248802

DLBS2411 Treatment For Functional Dyspepsia

Randomized Controlled Trial of DLBS2411 Treatment For Functional Dyspepsia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Dexa Medica Group · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-arm, prospective, double-blind, randomized and placebo-controlled study using DLBS2411 at a dose of 250 mg twice daily (before morning and evening meals), for a 4-week course of therapy, for the treatment of patients with functional dyspepsia (FD), and an additional 8 weeks after end of therapy (Week 12) for follow-up visit. 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. The mechanism altogether demonstrated DLBS2411's protective capacity to the gastric and colon mucosa by promoting mucous synthesis and stimulating mucosal blood flow. Having such mechanisms of action, DLBS2411 is hypothesized to benefit subjects with gastric acid disorders such as in functional dyspepsia, gastro-intestinal reflux disease (GERD), peptic-ulcer, and irritable bowel syndrome (IBS).

Detailed description

Study population will be patients with functional dyspepsia (FD) who come to the study site. There will be 100 subjects (50 subjects in each group) planned to be enrolled in the study. There will be 2 groups of treatment; Treatment 1: placebo DLBS2411 caplet Treatment 2: DLBS2411 250 mg caplet Each study medication will be administered 1 caplet twice daily, 30 minutes before meal, in the morning and evening. Eligible subjects will be randomly allocated to receive either Treatment 1 or Treatment 2 for 4 weeks, in a double blind fashion. Subjects will be instructed to come to the clinic every 2-week interval throughout the 4-week study period (at Week 2, and 4, respectively) and 8 weeks after the end of therapy (Week 12), for efficacy evaluation. The safety evaluation will be performed at Baseline and End of therapy (Week 4). Adverse events will be monitored at baseline and every follow-up visit including End of study (Week 12).

Conditions

• Functional Dyspepsia

Interventions

Type	Name	Description
DRUG	Placebo caplet of DLBS2411	1 caplet of placebo DLBS2411, twice daily
DRUG	DLBS2411	1 caplet of DLBS2411 250 mg, twice daily

Timeline

• Start date: 2022-12-09
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2022-02-21
• Last updated: 2026-02-17

Locations

8 sites across 1 country: Indonesia