Evaluating Diosmin and Hesperidin for Helicobacter Pylori Infection
Clinical Study to Evaluate the Possible Efficacy and Safety of Diosmin and Hesperidin Combined Therapy in Patients With Helicobacter Pylori Infection
This study is testing if a combination of Diosmin and Hesperidin can help people with Helicobacter pylori infections feel better and improve their test results.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sadat City University Academic / other |
| Locations | 1 site (Shibīn al Kawm) |
| Trial ID | NCT06546111 on ClinicalTrials.gov |
What this trial studies
This clinical study aims to evaluate the efficacy and safety of a combination therapy using Diosmin and Hesperidin in patients diagnosed with Helicobacter pylori infection. The study will assess the treatment's impact on stool antigen tests and serum levels of inflammatory biomarkers such as TNF-A and MDA. Participants will receive either the active treatment or a placebo, and the study will include both Phase 1 and Phase 2 assessments to ensure thorough evaluation of the intervention's effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with confirmed Helicobacter pylori infection who have not undergone prior eradication therapy.
Not a fit: Patients with a history of H. pylori eradication therapy or those with certain severe health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from Helicobacter pylori infections.
How similar studies have performed: While this approach is novel, similar studies have shown promise in evaluating alternative therapies for Helicobacter pylori infections.
Eligibility criteria
Show full inclusion / exclusion 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.).
Where this trial is running
Shibīn al Kawm
- National Liver Institute — Shibīn al Kawm, Egypt (Recruiting)
Study contacts
- Study coordinator: Aya Mosaad Swidan
- Email: aya.swidan@fop.usc.edu.eg
- Phone: 01208756300
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.