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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Completion pushed from Nov 2025 to Nov 2026 Primary completion date changed from estimate of Oct 2025 to Oct 15, 2025v5 Show 1 more changeShow less
    • Primary completion date changed from estimate of Oct 2025 to Oct 15, 2025
  2. Primary completion date: Oct 2024 to Oct 2025 Trial status: Recruiting to Active, Not Recruiting · Completion date: Dec 2024 to Nov 2025 · Site details revisedv4 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Dec 2024 to Nov 2025
    • Site details revised
  3. Primary completion date: Jun 2024 to Oct 2024 Completion date: Aug 2024 to Dec 2024v3 Show 1 more changeShow less
    • Completion date: Aug 2024 to Dec 2024
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 15, 2023 to Aug 15, 2023 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Jul 15, 2023 to Aug 15, 2023
    • Site details revised
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05957432
Lead Sponsor Ain Shams University
Conditions Helicobacter Pylori Infection
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov