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

Phase 1

Recruiting

• Conditions: Helicobacter Pylori Infection
• Interventions: Drug: Placebo; Drug: Daflon

• Registration Number: NCT06546111
• Lead Sponsor: Sadat City University

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-06
• Last Update Submitted: 2024-08-08
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-12
• Study Start: 2024-10-01
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 (placebo group)	Placebo	Patients will receive standard triple therapy (Omeprazole 20 mg cap PO BID + Clarithromycin 500 mg tab PO BID + Amoxicillin 1000 mg PO BID) and placebo tab PO BID for 14 days
Group 2 (intervention group)	Daflon	Patients will receive standard triple therapy (Omeprazole 20 mg cap PO BID + Clarithromycin 500 mg tab PO BID + Amoxicillin 1000 mg PO BID) and Diosmin/Hesperidin (Daflon®) 500mg tab PO BID for 14 days.

Primary Outcome Measures

Name	Time	Method
Eradication rate of helicobacter pylori infection	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 Outcome Measures

Name	Time	Method
Inflammatory biomarkers suppression	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)

Trial Locations

Locations (1)

National Liver Institute; 🇪🇬 Shibīn Al Kawm, Egypt