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Clinical Study to Evaluate the Possible Efficacy and Safety of Diosmin and Hesperidin Combined Therapy in Patients With Helicobacter Pylori Infection

Clinical Study to Evaluate the Possible Efficacy and Safety of Diosmin and Hesperidin Combined Therapy in Patients With Helicobacter Pylori Infection

Recruiting
18-75 years
All
Phase 1/2

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Overview

This study intends to assess the possible effectiveness and safety of Diosmin and Hesperidin combination in patients with Helicobacter pylori Infection through evaluating its effect on stool antigen test and serum levels of inflammatory biomarkers as(TNF-A and MDA).

Eligibility

Inclusion Criteria:

  • Confirmed H. pylori infection through stool antigen test.
    • Patients did not receive prior eradication therapy.
    • Male and female.
    • Age of 18-75 years old.
    • Good mental well-being to clearly understand the study's objectives, advantages and procedures.

Exclusion Criteria:

  • Age less than 18 years.
    • Patients with previous H. pylori eradication therapy.
    • Patients with hypersensitivity/allergy to the study medications.
    • Patients with history of using proton pump inhibitor, H2-blocker, antibiotics that affect H.

pylori in the last month.

  • Patients with history of using diosmin and/or hesperidin in the last month.
  • Patients with history of gastric tumor or gastrointestinal (GI) surgery.
  • Patients with concomitant severe disorders; cardiovascular, pulmonary, renal or hepatic, or active malignancy.
  • Pregnancy or breastfeeding.
  • History of drug misuse or recent alcohol consumption.
  • Patients with gall bladder disorders.
  • Patients on blood thinning agents (warfarin, clopidogril, aspirin, etc), anticonvulsants (carbamazepine and phenytoin), muscle relaxants (chlorzoxazone) and NSAID (diclofenac) in order to avoid potential pharmacodynamic and pharmacokinetic drug interactions with diosmin.
  • Patients on anti-inflammatory drugs and antioxidant drugs.
  • Patients with inflammatory conditions (ulcerative colitis, rheumatoid arthritis, etc.).
  • Patients with conditions associated with oxidative stress (smoking, COPD, etc.).

Study details
    Helicobacter Pylori Infection

NCT06546111

Sadat City University

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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