DLBS2411 Treatment for Functional Dyspepsia

Key Inclusion Criteria:

1. Signed informed consent prior to participation in the study.

2. Male or female subjects aged of 18 - 75 years old.

3. Meet Rome IV criteria for FD, which includes:

4. One or more of the following symptoms:

• bothersome postprandial fullness
• early satiation, that prevents finishing a regular meal, at least severaltimes 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 permonth (for female) for at least the past 3 months with symptom onset atleast 6 months prior to study Screening.

2. Having no evidence of structural or organic gastrointestinal (GI) disease thatis likely to explain the symptoms, as verified by a normalesophagogastroduodenoscopy (EGD) performed within the past 3 years.

3. Subjects who tested negative for Helicobacter pylori by urea breath-test,histological or rapid test during the screening period.

4. Able to take oral medication.

Key Exclusion Criteria:

1. Pregnancy, breast-feeding females.

2. Subjects suspected COVID-19 by clinical symptoms and rapid antigen test (reactiveresult) for SARS-COV-2.

3. GERD as confirmed by any documented history of endoscopic esophagitis, or clinicalsymptoms such as predominant heartburn or acid regurgitation, >2x/week in the prioryear.

4. History of or known or suspected Zollinger Ellison syndrome.

5. History of or known gastrointestinal malignancy or ulcers associated to malignancy.

6. Hepatic cirrhosis or abnormal liver laboratory findings (defined as >3xULN of ALT orAST).

7. Being under hemodialysis therapy or having advanced chronic kidney disease (definedas eGFR <60 mL/min).

8. History of or known congestive heart failure NYHA class III and IV, or any otheruncontrolled chronic diseases, such as: uncontrolled hypertension (systolic/diastolic blood pressure ≥160/100 mmHg); uncontrolled diabetes (HbA1c c ≥7%).

9. Currently known being afflicted by serious infection(s), or any known severeillness(es) which are judged by the Investigator could interfere with subjects'safety and/or study evaluation.

10. Taking medication affecting the gastrointestinal system within 2 weeks prior toScreening, 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 herbalmedicines.

11. Participation in any other clinical studies within 30 days prior to Screening.