NCT06546111 Clinical Study to Evaluate the Possible Efficacy and Safety of Diosmin and Hesperidin Combined Therapy in Patients With Helicobacter Pylori Infection
| NCT ID | NCT06546111 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Sadat City University |
| Condition | Helicobacter Pylori Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 46 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2025-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 46 participants in total. It began in 2024-10-01 with a primary completion date of 2025-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06546111 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Helicobacter Pylori Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06546111 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06546111 currently recruiting?
Yes, NCT06546111 is actively recruiting participants. Contact the research team at aya.swidan@fop.usc.edu.eg for enrollment information.
Where is the NCT06546111 trial being conducted?
This trial is being conducted at Shibīn al Kawm, Egypt.
Who is sponsoring the NCT06546111 clinical trial?
NCT06546111 is sponsored by Sadat City University. The trial plans to enroll 46 participants.