DLBS2411 Treatment For Functional Dyspepsia

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).

Conditions

• Functional Dyspepsia

Interventions

DRUG

Placebo caplet of DLBS2411

1 caplet of placebo DLBS2411, twice daily

DRUG

DLBS2411

1 caplet of DLBS2411 250 mg, twice daily

Sponsors & Collaborators

• Dexa Medica Group

  lead INDUSTRY

Principal Investigators

• Ari F Syam, Prof, MD, Sp.PD-KGEH · Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General Hospital, Jakarta Indonesia

• Agasjtya W Wardhana, MD, Sp.PD-KGEH · Department of Internal Medicine Budhi Asih Hospital, East Jakarta, Indonesia

• Nugroho B Santoso, MD, Sp.PD · Department of Internal Medicine Pasar Rebo Hospital, South Jakarta, Indonesia

• Hery D Purnomo, Dr, MD, Sp.PD-KGEH · Department of Internal Medicine Dr. Kariadi General Hospital, Semarang, Indonesia

• Triyanta Y Pramana, Dr, MD, Sp.PD-KGEH · Department of Internal Medicine Dr. Moewardi Hospital, Surakarta, Indonesia

• Mulyana Edi, MD, Sp.PD-KGEH · Department of Internal Medicine Fatmawati General Hospital, Jakarta,

• Coana Sukmagautama, MD, Sp.PD, M.Kes. · Department of Internal Medicine Universitas Sebelas Maret (UNS) Hospital, Sukoharjo, Indonesia

• Ulfa Kholili, MD, Sp.PD-KGEH · Department of Internal Medicine, Dr. Soetomo General Hospital, Surabaya, Indonesia

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-12-09

Primary Completion

2025-10-01

Completion

2025-10-01

Countries

• Indonesia

Study Locations