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Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia.
Sponsor: Rakibul Mostafa
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
Digestive enzyme 325mg
Digestive enzyme will be given to group A patient
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