Diosmin as Adjuvant Therapy in Treatment of Non-bleeding Peptic Ulcer

January 3, 2023 updated by: Ahmed Gamal Salah Abdelfatah, Tanta University
The aim of the study is to evaluate the safety and efficacy of diosmin as adjuvant therapy in treatment of non-bleeding peptic ulcer patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

-. Age 25-65 years old.

  • Patients of both gender (male and female).
  • Non-bleeding Peptic ulcer Patients (duodenal &gastric) diagnosed by endoscopy.

Exclusion Criteria:

  • The presence of other factors that can lead to gastric bleeding other than peptic ulcer.

    • Patients with cancerous disease
    • Breast-feeding.
    • Surgically altered stomach ( bariatric surgery),
    • Patient with liver disease.
  • Bleeding & perforated peptic ulcer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
this group will include 22 patients who will receive anti peptic ulcer only for 2 months.
Active Comparator: Diosmin group
this group will include 22 patients who will receive anti peptic ulcer and diosmin 500 mg twice daily for 2 months.
Drug: Diosmin
diosmin 500 mg twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assesment of improvement of symptoms as indicated by change in SAGIS scale.
Time Frame: 2 months
patients will undergo clinical assessment according to SAGIS scale at baseline and 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in Malondialdehyde (MDA) serum levels.
Time Frame: 2 months
blood samples will be collected at baseline and 2 months.
2 months
change in Prostaglandin E2 (PGE2) serum levels.
Time Frame: 2 months.
blood samples will be collected at baseline and 2 months.
2 months.
change in Endothelin-1 (ET-1) serum levels.
Time Frame: 2 months
blood samples will be collected at baseline and 2 months.
2 months
change in b-cell lymphoma 2(bcl-2) serum levels.
Time Frame: 2 months
blood samples will be collected at baseline and 2 months.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2022

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2025

Study Registration Dates

First Submitted

January 2, 2023

First Submitted That Met QC Criteria

January 3, 2023

First Posted (Actual)

January 4, 2023

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • diosmin peptic ulcer

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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