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

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

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.

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.