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Efficacy and Safety of Black Seed Oil With Vonoprazan Based Triple Therapy in Treatment of Helicobacter Pylori
Sponsor: Ain Shams University
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2023-08-15
Completion Date
2025-11
Last Updated
2025-01-29
Healthy Volunteers
No
Conditions
Interventions
Black Seed Oil Cap/Tab
possessed anti-H. pylori activity comparable to triple therapy and improved dyspepsia symptoms in infected patients
Vonoprazan, Amoxicillin and Clarithromycin
H pylori vonoprazan based treatment
Locations (1)
GIT department zagazig university hospital
Zagazig, Egypt