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Status unknownNCT06546111Updated Aug 12, 2024

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 interventional study of Placebo and Daflon in Helicobacter Pylori Infection, sponsored by Sadat City University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-12.

Sponsored by Sadat City University · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2024), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Helicobacter Pylori Infection
03

In context

Lead sponsor

Sadat City University is the lead sponsor of 25 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.).
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
46 participants (estimated)

Study arms

  • Placebo comparator
    Group 1 (placebo group)

    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

    Drug: Placebo

  • Experimental
    Group 2 (intervention group)

    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.

    Drug: Daflon

Interventions

  • DrugPlacebo

    Drug :placebo tab PO BID for 14 days.

  • DrugDaflon

    Daflon 500 mg tab PO BID for 14 days.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 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)

    Time frame: At baseline and after 6 weeks of initiation of therapy

07

Study locations

1 of 1 sites recruiting
  • National Liver Institute
    Shibīn al Kawm, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — Data will be supplied upon a reasonable request

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2024; primary completion for Oct 2025, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2024
First posted
Aug 9, 2024
StartEst.
Oct 1, 2024
Primary completionEst.
Oct 1, 2025
CompletionEst.
Oct 1, 2026
Last update
Aug 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06546111
Lead sponsor
Sadat City University
Responsible party
Aya Mosaad Zaki Swidan (Demonstrator, Sadat City University) — Principal investigator
First posted
Aug 9, 2024
Start date
Oct 1, 2024 (estimated)
Primary completion
Oct 1, 2025 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Aug 12, 2024

Study contacts

Aya Mosaad Swidan
Contact
aya.swidan@fop.usc.edu.eg
01208756300

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Diosmin

Other studies from this sponsor

Sadat City University

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