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

Primary Purpose

Non-bleeding Peptic Ulcer

Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Diosmin
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-bleeding Peptic Ulcer

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tanta UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control group

Diosmin group

Arm Description

this group will include 22 patients who will receive anti peptic ulcer only for 2 months.

this group will include 22 patients who will receive anti peptic ulcer and diosmin 500 mg twice daily for 2 months.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 2, 2023
Last Updated
January 3, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT05670457
Brief Title
Diosmin as Adjuvant Therapy in Treatment of Non-bleeding Peptic Ulcer
Official Title
Diosmin as Adjuvant Therapy in Treatment of Non-bleeding Peptic Ulcer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-bleeding Peptic Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
this group will include 22 patients who will receive anti peptic ulcer only for 2 months.
Arm Title
Diosmin group
Arm Type
Active Comparator
Arm Description
this group will include 22 patients who will receive anti peptic ulcer and diosmin 500 mg twice daily for 2 months.
Intervention Type
Drug
Intervention Name(s)
Diosmin
Intervention Description
diosmin 500 mg twice daily
Primary Outcome Measure Information:
Title
assesment of improvement of symptoms as indicated by change in SAGIS scale.
Description
patients will undergo clinical assessment according to SAGIS scale at baseline and 2 months
Time Frame
2 months
Secondary Outcome Measure Information:
Title
change in Malondialdehyde (MDA) serum levels.
Description
blood samples will be collected at baseline and 2 months.
Time Frame
2 months
Title
change in Prostaglandin E2 (PGE2) serum levels.
Description
blood samples will be collected at baseline and 2 months.
Time Frame
2 months.
Title
change in Endothelin-1 (ET-1) serum levels.
Description
blood samples will be collected at baseline and 2 months.
Time Frame
2 months
Title
change in b-cell lymphoma 2(bcl-2) serum levels.
Description
blood samples will be collected at baseline and 2 months.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed G Abdelfatah
Phone
201017458534
Email
ahmed131692@pharm.tanta.edu.eg
Facility Information:
Facility Name
Tanta University
City
Tanta
State/Province
El Gharbia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed G Abdelfatah
Phone
201017458534
Email
ahmed131692@pharm.tanta.edu.eg

12. IPD Sharing Statement

Learn more about this trial

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

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