Efficacy and Safety of Black Seed Oil With Vonoprazan Based Triple Therapy in Treatment of Helicobacter Pylori

• Status: ACTIVE_NOT_RECRUITING
• Trial end date: 2025-11-01

Summary

The aim of this study is to:

• Evaluation of efficacy and safety of adding black seed oil with vonoprazan triple therapy ( vonoprazan ,clarithromycin and amoxicillin ) in eradication of Helicobacter pylori infection and this will be done through evaluation of:

A. Efficacy by:

1. determination of successful eradication,which will be considered to be achieved on the basis of a negative stool antigen test four weeks after the end of treatment using Stool Ag test

2. The effect of N. Sativa on:

I. Oxidative stress by measuring MDA II. Inflammation by measuring IL1B as inflammatory markers

B. Safety will be done through:

Monitoring of expected treatment related adverse effects (black seed oil and vonoprazan triple therapy ) will be done through the whole study period.

C. Symptoms evaluation using the Gastrointestinal symptom rating scale D. Assessment of patient's quality of life using SF36 questionnaire

• Phase: PHASE2

Details

• Lead Sponsor: Ain Shams University
• Treatments: 1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Amoxicillin; Clarithromycin