MedTrace Logo

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

NCT07578402 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

  • Dyspepsia
  • Functioanl Dyspepsia
  • Epigastric Pain Syndrome
  • Epigastric Fullness

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

Sponsors & Collaborators

  • Rakibul Mostafa

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2026-12-31
Completion
2027-02-28

Countries

  • Bangladesh

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07578402 on ClinicalTrials.gov