Helicobacter Pylori InfectionPhase 1/2NCT06546111
Clinical Study to Evaluate the Possible Efficacy and Safety of Diosmin and Hesperidin Combined Therapy in Patients With Helicobacter Pylori Infection
A Phase 1/2 study testing Daflon in people with Helicobacter Pylori Infection, run by Sadat City University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Daflon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Oct 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.).
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Placebo, Daflon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Drug :placebo tab PO BID for 14 days.
DaflonDrug
Daflon 500 mg tab PO BID for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Placebo |
| 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. Receives: Drug: Daflon |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline and after 6 weeks of initiation of therapy
Secondary outcomes (1)
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)
Measured: At baseline and after 6 weeks of initiation of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sadat City University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mosaad Zaki Swidan, Sadat City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06546111
- Sponsor's protocol ID
- 00612/2024
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be supplied upon a reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Possible Efficacy and Safety of Diosmin and Hesperidin Combined Therapy in Patients With Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT06546111
- Acronym / sponsor ID
- 00612/2024
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Sadat City UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (placebo group) | Placebo comparator | Drug: PlaceboPatients 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 | Drug: DaflonPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed H. pylori infection through stool antigen test.
Key exclusion criteria (15 listed)
- Age less than 18 years.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboDrug :placebo tab PO BID for 14 days. | Drug | Group 1 (placebo group) |
| DaflonDaflon 500 mg tab PO BID for 14 days. | Drug | Group 2 (intervention group) |
Primary outcome
Eradication rate of helicobacter pylori infection
Time frame: 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).
1 secondary outcome
Inflammatory biomarkers suppression
Time frame: At baseline and after 6 weeks of initiation of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: No. Data will be supplied upon a reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Daflon in people with Helicobacter Pylori Infection, run by Sadat City University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya Mosaad Swidan (01208756300, aya.swidan@fop.usc.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate of helicobacter pylori infection (time frame: At baseline and after 6 weeks of initiation of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.