Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia.

Starting soon · Phase 4

Conditions studied: Dyspepsia, Functioanl Dyspepsia, Epigastric Pain Syndrome, Epigastric Fullness

In brief

The goal of this clinical trial is to assess the effect of digestive enzymes in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drug by recording the patient reported adverse events. The main questions it aims to answer are: Does drug digestive enzymes has any effect on patients with functional dyspepsia? What medical problems do participants have when taking drug digestive enzymes? Researcher will compare drug digestive enzymes to a control group taking standard first line treatment only. Participants will: Take drug digestive enzymes 325 milligrams 3 times daily, every day for 4 weeks along with standard first line treatment. A second group will be taken as control arm who will be kept on standard first line treatment only for 4 weeks. They will visit the hospital 2 weekly, and their symptoms will be assessed by a 5-point Likert Scale at baseline, week 2 and 4. Additionally, patient reported adverse events will be documented.

Key facts

Study ID

NCT07578402

Run by

Rakibul Mostafa

People needed

120

Starts

2026-05-15

Expected to finish

2027-02-28

Last updated by the study team

2026-05-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age 18 years or more
• Patients with FD diagnosed according to ROME IV criteria

You may not qualify if…

• Structural lesion in endoscopy and positive H. pylori status
• History of malignancy, liver and biliary tract disease, diabetes mellitus, chronic kidney disease, thyroid disorders
• Psychiatric disorders
• Previous history gastrointestinal surgery
• Any history of hypersensitivity, adverse effect, or ineffectiveness with digestive enzyme
• Pregnancy and breastfeeding.

Where it is running

• Dhaka Medical College — Dhaka, Bangladesh

Full record on ClinicalTrials.gov

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