RecruitingPhase 1Phase 2NCT06546111

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

Sponsor

Sadat City University

Enrollment

46 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Helicobacter Pylori Infection

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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 Criteria15

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.).