DLBS2411 Treatment For Functional Dyspepsia

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).

Key Inclusion Criteria:

• Signed informed consent prior to participation in the study.
• Male or female subjects aged of 18 - 75 years old.
• Meet Rome IV criteria for FD, which includes:

• One or more of the following symptoms:

• bothersome postprandial fullness
• early satiation, that prevents finishing a regular meal, at least several times per week.
• epigastric pain, epigastric burning. The symptoms are persistently present (i.e. occurring at least one day per month (for male) or 2-3 days per month (for female) for at least the past 3 months with symptom onset at least 6 months prior to study Screening.
• Having no evidence of structural or organic gastrointestinal (GI) disease that is likely to explain the symptoms, as verified by a normal esophagogastroduodenoscopy (EGD) performed within the past 3 years.
• Subjects who tested negative for Helicobacter pylori by urea breath-test, histological or rapid test during the screening period.
• Able to take oral medication.

Key Exclusion Criteria:

• Pregnancy, breast-feeding females.
• Subjects suspected COVID-19 by clinical symptoms and rapid antigen test (reactive result) for SARS-COV-2.
• GERD as confirmed by any documented history of endoscopic esophagitis, or clinical symptoms such as predominant heartburn or acid regurgitation, >2x/week in the prior year.
• History of or known or suspected Zollinger Ellison syndrome.
• History of or known gastrointestinal malignancy or ulcers associated to malignancy.
• Hepatic cirrhosis or abnormal liver laboratory findings (defined as >3xULN of ALT or AST).
• Being under hemodialysis therapy or having advanced chronic kidney disease (defined as eGFR <60 mL/min).
• History of or known congestive heart failure NYHA class III and IV, or any other uncontrolled chronic diseases, such as: uncontrolled hypertension (systolic/diastolic blood pressure ≥160/100 mmHg); uncontrolled diabetes (HbA1c c ≥7%).
• Currently known being afflicted by serious infection(s), or any known severe illness(es) which are judged by the Investigator could interfere with subjects' safety and/or study evaluation.
• Taking medication affecting the gastrointestinal system within 2 weeks prior to Screening, such as: prokinetics, acid release inhibitors (histamine-2-receptor [H2]- antagonists, proton pump inhibitors [PPI], or potassium-competitive acid blockers), gastric mucosa protectors (sucralfate, rebamipide), and any gastric-relevant herbal medicines.
• Participation in any other clinical studies within 30 days prior to Screening.