Non-bleeding Peptic UlcerPhase 3NCT05670457
Diosmin as Adjuvant Therapy in Treatment of Non-bleeding Peptic Ulcer
A Phase 3 study testing Diosmin in people with Non-bleeding Peptic Ulcer, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Non-bleeding Peptic Ulcer
- What is being tested?
- Diosmin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2022to Jun 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -. Age 25-65 years old.
- Patients of both gender (male and female).
- Non-bleeding Peptic ulcer Patients (duodenal \&gastric) diagnosed by endoscopy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El Gharbia
Ahmed G Abdelfatah, 201017458534, ahmed131692@pharm.tanta.edu.eg
About this study
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.
- Conditions
- Non-bleeding Peptic Ulcer
- Being tested
- Diosmin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiosminDrug
diosmin 500 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Diosmin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
Secondary outcomes (4)
change in Malondialdehyde (MDA) serum levels.
blood samples will be collected at baseline and 2 months.
Measured: 2 months
change in Prostaglandin E2 (PGE2) serum levels.
blood samples will be collected at baseline and 2 months.
Measured: 2 months.
change in Endothelin-1 (ET-1) serum levels.
blood samples will be collected at baseline and 2 months.
Measured: 2 months
change in b-cell lymphoma 2(bcl-2) serum levels.
blood samples will be collected at baseline and 2 months.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start30 Jun 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-bleeding Peptic UlcerStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Gamal Salah Abdelfatah, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670457
- Sponsor's protocol ID
- diosmin peptic ulcer
- Status last verified
- Jan 2023
- First submitted
- 2 Jan 2023
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diosmin as Adjuvant Therapy in Treatment of Non-bleeding Peptic Ulcer
- ClinicalTrials.gov ID
- NCT05670457
- Acronym / sponsor ID
- diosmin peptic ulcer
- Conditions
- Non-bleeding Peptic Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Jun 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –this group will include 22 patients who will receive anti peptic ulcer only for 2 months. |
| Diosmin group | Active comparator | Drug: Diosminthis group will include 22 patients who will receive anti peptic ulcer and diosmin 500 mg twice daily for 2 months. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- -. Age 25-65 years old.
- Patients of both gender (male and female).
- Non-bleeding Peptic ulcer Patients (duodenal \&gastric) diagnosed by endoscopy.
Key exclusion criteria (6 listed)
- The presence of other factors that can lead to gastric bleeding other than peptic ulcer.
- Bleeding \& perforated peptic ulcer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diosmindiosmin 500 mg twice daily | Drug | Diosmin group |
Primary outcome
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
4 secondary outcomes
change in Malondialdehyde (MDA) serum levels.
Time frame: 2 months
change in Prostaglandin E2 (PGE2) serum levels.
Time frame: 2 months.
change in Endothelin-1 (ET-1) serum levels.
Time frame: 2 months
change in b-cell lymphoma 2(bcl-2) serum levels.
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diosmin in people with Non-bleeding Peptic Ulcer, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed G Abdelfatah (201017458534, ahmed131692@pharm.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assesment of improvement of symptoms as indicated by change in SAGIS scale. (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.