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NCT Number: NCT06546111

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

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).

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Liver Institute

Shibīn al Kawm, Egypt

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

Placebo

Drug

Drug :placebo tab PO BID for 14 days.

Daflon

Drug

Daflon 500 mg tab PO BID for 14 days.

Primary outcomes

  1. Eradication rate of helicobacter pylori infection

    Time frame: At baseline and after 6 weeks of initiation of therapy

    The primary outcome is the improvement of eradication rate of H. pylori infection which is measured by stool antigen test (Negative result).

Secondary outcomes

  1. Inflammatory biomarkers suppression

    Time frame: At baseline and after 6 weeks of initiation of therapy

    The secondary outcome is the change in the measured specific biomarkers (TNF-α which is measured by pg /mL unit), (MDA which is measured by µmol/L)

Study contacts

Contact information is provided by the study sponsor or research team.

Aya Mosaad Swidan

CONTACT

[email protected]

01208756300

Sponsors and collaborators

Lead sponsor

Sadat City University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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