Status:
RECRUITING
Clinical Study to Evaluate the Possible Efficacy and Safety of Diosmin and Hesperidin Combined Therapy in Patients With Helicobacter Pylori Infection
Lead Sponsor:
Sadat City University
Conditions:
Helicobacter Pylori Infection
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.).
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT06546111
Start Date
October 1 2024
End Date
October 1 2026
Last Update
August 12 2024
Active Locations (1)
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1
National Liver Institute
Shibīn al Kawm, Egypt