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).

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Placebo; Drug: Daflon

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Aya Mosaad Swidan; Phone Number: 01208756300; Email: aya.swidan@fop.usc.edu.eg

Study Locations

• Egypt
  • Shibīn Al Kawm, Egypt
    • Recruiting
    • National Liver Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1 (placebo group); 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	Drug: Placebo; Drug :placebo tab PO BID for 14 days.
Experimental: Group 2 (intervention group); 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.	Drug: Daflon; Daflon 500 mg tab PO BID for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rate of helicobacter pylori infection	The primary outcome is the improvement of eradication rate of H. pylori infection which is measured by stool antigen test (Negative result).	At baseline and after 6 weeks of initiation of therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory biomarkers suppression	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)	At baseline and after 6 weeks of initiation of therapy

Collaborators and Investigators

• Sponsor: Sadat City University

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 9, 2024

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections
• Other Study ID Numbers: 00612/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be supplied upon a reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No