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

NCT06546111 | Recruiting Phase 1

• 1 other identifier: 00612/2024
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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).

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Inflammatory biomarkers suppression

  At baseline and after 6 weeks of initiation of therapy

Study Arms (2)

Group 1 (placebo group)

PLACEBO COMPARATOR

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

Group 2 (intervention group)

EXPERIMENTAL

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

Interventions

Placebo DRUG

Drug :placebo tab PO BID for 14 days.

Group 1 (placebo group)

Daflon DRUG

Daflon 500 mg tab PO BID for 14 days.

Group 2 (intervention group)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Sadat City University: lead

Study Sites (1)

National Liver Institute

Shibīn al Kawm, Egypt

RECRUITING

MeSH Terms

Interventions

Diosmin

Intervention Hierarchy (Ancestors)

Flavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Aya Mosaad Swidan

CONTACT

01208756300; aya.swidan@fop.usc.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Demonstrator

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: October 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)