Helicobacter Pylori Infection
Conditions
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 test and serum levels of inflammatory biomarkers as(TNF-A and MDA).
Interventions
DRUGPlacebo
Drug :placebo tab PO BID for 14 days.
DRUGDaflon
Daflon 500 mg tab PO BID for 14 days.
Sponsors
Sadat City University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eradication rate of helicobacter pylori infection | At baseline and after 6 weeks of initiation of therapy | The primary outcome is the improvement of eradication rate of H. pylori infection which is measured by stool antigen test (Negative result). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory biomarkers suppression | At baseline and after 6 weeks of initiation of therapy | The secondary outcome is the change in the measured specific biomarkers (TNF-α which is measured by pg /mL unit), (MDA which is measured by µmol/L) |
Countries
Egypt
Contacts
Primary ContactAya Mosaad Swidan
Outcome results
None listed