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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (placebo group) | Placebo Comparator | 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 |
|
| Group 2 (intervention group) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Drug :placebo tab PO BID for 14 days. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication rate of helicobacter pylori infection | The primary outcome is the improvement of eradication rate of H. pylori infection which is measured by stool antigen test (Negative result). | At baseline and after 6 weeks of initiation of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory biomarkers suppression | 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) | At baseline and after 6 weeks of initiation of therapy |
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Inclusion Criteria:
Confirmed H. pylori infection through stool antigen test.
Exclusion Criteria:
Age less than 18 years.
pylori in the last month.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aya Mosaad Swidan | Contact | 01208756300 | aya.swidan@fop.usc.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Liver Institute | Recruiting | Shibīn al Kawm | Egypt |
Data will be supplied upon a reasonable request
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| Daflon |
| Drug |
Daflon 500 mg tab PO BID for 14 days. |
|
| ID | Term |
|---|---|
| D004145 | Diosmin |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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