Actively Recruiting
Clinical Study to Evaluate the Possible Efficacy and Safety of Diosmin and Hesperidin Combined Therapy in Patients With Helicobacter Pylori Infection
Led by Sadat City University · Updated on 2024-08-12
46
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the possible effectiveness and safety of combining Diosmin and Hesperidin in treating patients with Helicobacter pylori infection. The study focuses on evaluating how this combination affects the eradication of the infection as well as its impact on inflammatory markers such as TNF-A and MDA. This is a randomized, double-blind trial involving adult patients aged 18 to 75 years who have confirmed H. pylori infection. Participants are randomly assigned to one of two groups. One group receives the standard triple therapy consisting of Omeprazole, Clarithromycin, and Amoxicillin along with placebo tablets twice daily for 14 days. The other group receives the same standard triple therapy plus Diosmin/Hesperidin (Daflon) tablets twice daily for 14 days. Both treatments are administered orally. During the trial, patients are assessed at the start and six weeks after beginning therapy to measure the eradication rate of H. pylori infection using stool antigen tests. Researchers also measure levels of inflammatory biomarkers to observe any changes. Safety and response to treatment are monitored throughout the study, which lasts at least six weeks from therapy initiation.
CONDITIONS
Brief Title
Clinical Study to Evaluate the Possible Efficacy and Safety of Diosmin and Hesperidin Combined Therapy in Patients With Helicobacter Pylori Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed H. pylori infection through stool antigen test
- No prior eradication therapy for H. pylori
- Male or female
- Age between 18 and 75 years
- Good mental well-being to understand study objectives and procedures
You will not qualify if you...
- Age under 18 years
- Previous H. pylori eradication therapy
- Allergy or hypersensitivity to study medications
- Use of proton pump inhibitors, H2-blockers, or antibiotics affecting H. pylori within the last month
- Use of diosmin and/or hesperidin in the last month
- History of gastric tumor or gastrointestinal surgery
- Severe cardiovascular, pulmonary, renal, or hepatic disorders, or active malignancy
- Pregnancy or breastfeeding
- History of drug misuse or recent alcohol consumption
- Gall bladder disorders
- Use of blood thinners, anticonvulsants, muscle relaxants, or NSAIDs that may interact with diosmin
- Use of anti-inflammatory or antioxidant drugs
- Inflammatory conditions such as ulcerative colitis or rheumatoid arthritis
- Conditions linked to oxidative stress like smoking or COPD
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants receive either standard triple therapy combined with placebo or standard triple therapy combined with Diosmin/Hesperidin (Daflon®) tablets twice daily for 14 days.
Daily medication for 14 days with at least 1 visit during treatment
Duration - 6 weeks after initiation of therapy
Participants are monitored to evaluate the eradication of Helicobacter pylori infection and suppression of inflammatory biomarkers after treatment.
1 follow-up visit (in-person) approximately 6 weeks after treatment starts
Trial Site Locations
Total: 1 location
1
National Liver Institute
Shibīn al Kawm, Egypt
Actively Recruiting
Research Team
A
Aya Mosaad Swidan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here