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

NCT05957432 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-01-29

No results posted yet for this study

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

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Black Seed Oil Cap/Tab

possessed anti-H. pylori activity comparable to triple therapy and improved dyspepsia symptoms in infected patients

DRUG

Vonoprazan, Amoxicillin and Clarithromycin

H pylori vonoprazan based treatment

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • sara M zaky, ass.prof · faculty of pharmacy Ain shams university

  • yasser A Elnaggar, prof · faculty of medicine zagazig university

  • sara F Mohamed, lecturer · faculty of pharmacy Ainshams university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-15
Primary Completion
2025-10-31
Completion
2025-11-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05957432 on ClinicalTrials.gov