Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digestive enzyme 325mg, PPI 20 mg + Domperidone 10 mg.
- Who it may be relevant to
- Registry conditions: Dyspepsia, Functioanl Dyspepsia, Epigastric Pain Syndrome, Epigastric Fullness. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bangladesh
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia - A Randomised, Open Label Trial
Overview
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.
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
Primary outcome measures
- Change in dyspeptic symptom [Time frame: At baseline and then at week 2 and 4 after randomization]
Secondary outcome measures (3)
- See the effect of digestive enzymes compared to first line treatment only [Time frame: At baseline and then at week 2 and 4 after randomization]
- Adverse events [Time frame: Through study completion, an average of 1 year]
- Persistence of symptom improvement or recurrence of dyspeptic symptoms [Time frame: At week 8 after randomization]
Eligibility criteria
Inclusion criteria
- Age 18 years or more
- Patients with FD diagnosed according to ROME IV criteria
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Bangladesh · 1 center
- Dhaka Medical College — Dhaka
Identifiers
NCT: NCT07578402 · IRB-DMC/2025/258