Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05957432
PHASE2

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

Sponsor: Ain Shams University

View on ClinicalTrials.gov

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

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

Locations (1)

GIT department zagazig university hospital

Zagazig, Egypt