ClinicalTrials.Veeva

Menu

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

S

Sadat City University

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

Helicobacter Pylori Infection

Treatments

Drug: Placebo
Drug: Daflon

Study type

Interventional

Funder types

Other

Identifiers

NCT06546111
00612/2024

Details and patient eligibility

About

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).

Enrollment

46 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

46 participants in 2 patient groups, including a placebo group

Group 1 (placebo group)
Placebo Comparator group
Description:
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
Treatment:
Drug: Placebo
Group 2 (intervention group)
Experimental group
Description:
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.
Treatment:
Drug: Daflon

Trial contacts and locations

1

Loading...

Central trial contact

Aya Mosaad Swidan

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems