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

• Sponsor: Tanta University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05670457
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 35.1
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-bleeding Peptic Ulcer	Drug: Diosmin	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Diosmin as Adjuvant Therapy in Treatment of Non-bleeding Peptic Ulcer
• Actual Study Start Date: Jun 30, 2022
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. assesment of improvement of symptoms as indicated by change in SAGIS scale. [2 months]

   patients will undergo clinical assessment according to SAGIS scale at baseline and 2 months

Secondary Outcome Measures

1. change in Malondialdehyde (MDA) serum levels. [2 months]

   blood samples will be collected at baseline and 2 months.

2. change in Prostaglandin E2 (PGE2) serum levels. [2 months.]

   blood samples will be collected at baseline and 2 months.

3. change in Endothelin-1 (ET-1) serum levels. [2 months]

   blood samples will be collected at baseline and 2 months.

4. change in b-cell lymphoma 2(bcl-2) serum levels. [2 months]

   blood samples will be collected at baseline and 2 months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tanta University	Tanta	El Gharbia	Egypt

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Gamal Salah Abdelfatah, principal investigator, Tanta University
• ClinicalTrials.gov Identifier: NCT05670457
• Other Study ID Numbers: diosmin peptic ulcer
• First Posted: Jan 4, 2023
• Last Update Posted: Jan 4, 2023
• Last Verified: Jan 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Peptic Ulcer; Ulcer

Study Results

No Results Posted as of Jan 4, 2023