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

NCT05957432 Phase 2 ACTIVE_NOT_RECRUITING

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

Details

Lead sponsor	Ain Shams University
Phase	Phase 2
Status	ACTIVE_NOT_RECRUITING
Enrolment	90
Start date	2023-08-15
Completion	2025-11

Conditions

• Helicobacter Pylori Infection

Interventions

• Black Seed Oil Cap/Tab
• Vonoprazan, Amoxicillin and Clarithromycin

Primary outcomes

• Stool antigen test at baseline ( pre-intervention) — at baseline for diagnosis of helicobacter pylori (before start of triple therapy )
  Stool Antigen Test: The test is qualitative and is based on the detection of H. pylori antigen in human feces ( positive test )
• Change of Stool antigen test after 4 weeks from triple therapy — after 4 weeks from triple therapy
  evaluate successful eradication of helicobacter pylori by negative stool Ag test

Countries

Egypt