NCT05670457

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2022

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

1.9 years

First QC Date

January 2, 2023

Last Update Submit

January 3, 2023

Conditions

Non-bleeding Peptic Ulcer

Outcome Measures

Primary Outcomes (1)

  • 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

    2 months

Secondary Outcomes (4)

  • change in Malondialdehyde (MDA) serum levels.

    2 months

  • change in Prostaglandin E2 (PGE2) serum levels.

    2 months.

  • change in Endothelin-1 (ET-1) serum levels.

    2 months

  • change in b-cell lymphoma 2(bcl-2) serum levels.

    2 months

Study Arms (2)

Control group

NO INTERVENTION

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

Diosmin group

ACTIVE COMPARATOR

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

Drug: Diosmin

Interventions

DiosminDRUG

diosmin 500 mg twice daily

Diosmin group

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 25-65 years old.
  • Patients of both gender (male and female).
  • Non-bleeding Peptic ulcer Patients (duodenal \&gastric) diagnosed by endoscopy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El Gharbia, Egypt

RECRUITING

MeSH Terms

Interventions

Diosmin

Intervention Hierarchy (Ancestors)

FlavonesFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Ahmed G Abdelfatah

CONTACT

201017458534ahmed131692@pharm.tanta.edu.eg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 2, 2023

First Posted

January 4, 2023

Study Start

June 30, 2022

Primary Completion

June 1, 2024

Study Completion

June 1, 2025

Last Updated

January 4, 2023

Record last verified: 2023-01

Locations

EG(1)