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

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

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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