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NOT YET RECRUITING
NCT07578402
PHASE4

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

Sponsor: Rakibul Mostafa

View on ClinicalTrials.gov

Summary

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.

Official title: Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia - A Randomised, Open Label Trial

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-05-15

Completion Date

2027-02-28

Last Updated

2026-05-11

Healthy Volunteers

Yes

Interventions

DRUG

Digestive enzyme 325mg

Digestive enzyme will be given to group A patient

DRUG

PPI 20 mg + Domperidone 10 mg

Group B patient will get first line treatment only for 1 month

Locations (1)

Dhaka Medical College

Dhaka, Bangladesh