Recruiting NCT06546111
Clinical Study to Evaluate the Possible Efficacy and Safety of Diosmin and Hesperidin Combined Therapy in Patients With Helicobacter Pylori Infection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, Daflon.
- Who it may be relevant to
- Registry conditions: Helicobacter Pylori Infection. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- Drug Placebo
Drug :placebo tab PO BID for 14 days. - Drug Daflon
Daflon 500 mg tab PO BID for 14 days.
Primary outcome measures
- Eradication rate of helicobacter pylori infection [Time frame: At baseline and after 6 weeks of initiation of therapy]
Secondary outcome measures (1)
- Inflammatory biomarkers suppression [Time frame: At baseline and after 6 weeks of initiation of therapy]
Eligibility criteria
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.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- National Liver Institute — Shibīn al Kawm
Identifiers
NCT: NCT06546111 · 00612/2024