Ulcerative ColitisPhase 3NCT05626166
the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis
A Phase 3 study testing Diosmin in people with Ulcerative Colitis, run by Tanta University at 1 site in Egypt.
Trial summary
This is a randomized, controlled study evaluating diosmin tablets administered daily for 3 months. The purpose of the study is to evaluate the efficacy and safety of diosmin in the treatment of mild to moderately active ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Diosmin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to Nov 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old.
- Both male and female sex.
- Newly diagnosed patients with mild and moderate ulcerative colitis and treated with 5-aminosalicylic acid (mesalamine).
Who cannot join
- Patients with severe ulcerative colitis.
- Patients with colorectal cancer.
- Patients on rectal or systemic steroids.
- Patients on immunosuppressants or biological therapies.
- Patients with previously failed treatment with sulphasalazine.
- Patients with known allergy to study medications.
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- History of complete or partial colectomy.
- Patients with heart diseases and arrhythmia.
- Patients on blood thinning agents.
- Patients on anticoagulants (warfarin), anticonvulsants (carbamazepine and phenytoin), muscle relaxants (chlorzoxazone) and non-steroidal anti-inflammatory drugs (diclofenac).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta university hospital
Tanta
Tanta University Hospitals
About this study
Official title: Clinical Study Evaluating the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis Treated With Mesalamine
This is a randomized, controlled study evaluating diosmin tablets administered daily for 3 months. The purpose of the study is to evaluate the efficacy and safety of diosmin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using modified truelove and witt's classification.
Read the detailed description
This study aims at evaluating the efficacy and safety of diosmin as add-on therapy to mesalamine in patients with mild to moderate ulcerative colitis.
This proof of concept study will be designed to be a randomized, double-blind, placebo controlled parallel study. The study will be conducted on 60 patients with mild to moderate ulcerative colitis receiving mesalamine. The patient will be followed for 3 months.
The patients will be randomised into the following two groups:
Group I (Control group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo tablets twice daily for 3 months.
Group II: (Diosmin group; n=30) which will receive mesalamine 1000 mg three times daily plus diosmin 600 mg twice daily for 3 months.
All participants included in this study will be subjected to the following:
- Demography, history, and physical examination
- Blood sample collection and biochemical assessment At baseline and after the intervention, 10 ml of venous blood will be withdrawn from each participant.
3 ml of blood will be used for immediate determination of routine parameters including:
- Hemoglobin concentration.
- Ertherythrocyte sedimentation rate (ESR).
- Prothrombin time.
Two ml of blood will be immediately centrifuged at 3000 rpm for 10 min for immediate determination of:
- Serum albumin
The remaining 5 ml of blood will be used for the analysis of the biological parameters which include:
- Malondialdehyde (MDA) as oxidative stress marker (colorimetry).
- Tumor necrosis factor-alpha (TNF-α) as pro inflammatory marker (ELISA).
- Caspase-3 as a potential marker for apoptosis (ELISA). 3. Clinical assessment
Clinical assessment will be done through determination of:
- Disease severity which will be assessed according to the modified Truelove and Witt's classification.
- The activity index (AI) for ulcerative colitis which is expressed as follows:
AI = 60 x blood stool + 13 x bowel movements (frequency of defection) + 0.5 x ESR - 4 x Hb - 15 x albumin + 200.
- Health-related Quality of Life (HRQoL) using The Short Inflammatory Bowel Disease Questionnaire (SIBDQ).
- Assessement of pain score through the brief pain inventory short form "BPI-SF" worst item.
- Conditions
- Ulcerative Colitis
- Being tested
- Placebo, Diosmin
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
placebo tablets twice daily
DiosminDrug
Also called diosimax
diosmin 600 mg twice daily
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Group I (Control group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo tablets twice daily for 3 months. Receives: Drug: Placebo |
| diosmin group | Experimental | Group II: (Diosmin group; n=30) which will receive mesalamine 1000 mg three times daily plus diosmin 600 mg twice daily for 3 months. Receives: Drug: Diosmin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change in Truelove and Witt's classification.
Measured: at baseline then after 3 months
the change in health related quality of life (HRQoL) questionnaire
Measured: at baseline then after 3 months
Secondary outcomes (1)
the change in the measured biological parameters (TNF alpha, MDA, caspase-3)
Measured: at baseline then after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start15 Dec 2022
- Primary completionNov 2023 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- Model description
- This proof of concept study will be designed to be a randomized, double-blind, placebo controlled parallel study. The study will be conducted on 60 patients with mild to moderate ulcerative colitis receiving mesalamine. Patients will be recruited from Tropical Medicine Department, Tanta University Hospital, Tanta, Egypt. The patient will be followed for 3 months. The blindness will be maintained by the similarity in appearance, color and shape between placebo and diosmin tablets. The patients will be randomized in a 1:1 ratio by neutral researcher using sealed envelopes methods with assignment codes into the following two groups: Group I (Control group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo tablets twice daily for 3 months. Group II: (Diosmin group; n=30) which will receive mesalamine 1000 mg three times daily plus diosmin 600 mg twice daily for 3 months
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira B ismail, Tanta University
- Investigators
- tarek M mostafa, professor, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626166
- Sponsor's protocol ID
- 36031/11/22
- Status last verified
- Apr 2023
- First submitted
- 9 Nov 2022
- Last updated
- 12 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Efficacy and Safety of Diosmin in Patients With Ulcerative Colitis Treated With Mesalamine
- ClinicalTrials.gov ID
- NCT05626166
- Acronym / sponsor ID
- 36031/11/22
- Conditions
- Ulcerative Colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 23 Nov 2022 (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.
This is a randomized, controlled study evaluating diosmin tablets administered daily for 3 months. The purpose of the study is to evaluate the efficacy and safety of diosmin in the treatment of mild to moderately active ulcerative colitis. Disease activity will be measured using modified truelove and witt's classification.
Detailed description
This study aims at evaluating the efficacy and safety of diosmin as add-on therapy to mesalamine in patients with mild to moderate ulcerative colitis.
This proof of concept study will be designed to be a randomized, double-blind, placebo controlled parallel study. The study will be conducted on 60 patients with mild to moderate ulcerative colitis receiving mesalamine. The patient will be followed for 3 months.
The patients will be randomised into the following two groups:
Group I (Control group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo tablets twice daily for 3 months.
Group II: (Diosmin group; n=30) which will receive mesalamine 1000 mg three times daily plus diosmin 600 mg twice daily for 3 months.
All participants included in this study will be subjected to the following:
- Demography, history, and physical examination
- Blood sample collection and biochemical assessment At baseline and after the intervention, 10 ml of venous blood will be withdrawn from each participant.
3 ml of blood will be used for immediate determination of routine parameters including:
- Hemoglobin concentration.
- Ertherythrocyte sedimentation rate (ESR).
- Prothrombin time.
Two ml of blood will be immediately centrifuged at 3000 rpm for 10 min for immediate determination of:
- Serum albumin
The remaining 5 ml of blood will be used for the analysis of the biological parameters which include:
- Malondialdehyde (MDA) as oxidative stress marker (colorimetry).
- Tumor necrosis factor-alpha (TNF-α) as pro inflammatory marker (ELISA).
- Caspase-3 as a potential marker for apoptosis (ELISA). 3. Clinical assessment
Clinical assessment will be done through determination of:
- Disease severity which will be assessed according to the modified Truelove and Witt's classification.
- The activity index (AI) for ulcerative colitis which is expressed as follows:
AI = 60 x blood stool + 13 x bowel movements (frequency of defection) + 0.5 x ESR - 4 x Hb - 15 x albumin + 200.
- Health-related Quality of Life (HRQoL) using The Short Inflammatory Bowel Disease Questionnaire (SIBDQ).
- Assessement of pain score through the brief pain inventory short form "BPI-SF" worst item.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This proof of concept study will be designed to be a randomized, double-blind, placebo controlled parallel study. The study will be conducted on 60 patients with mild to moderate ulcerative colitis receiving mesalamine. Patients will be recruited from Tropical Medicine Department, Tanta University Hospital, Tanta, Egypt. The patient will be followed for 3 months. The blindness will be maintained by the similarity in appearance, color and shape between placebo and diosmin tablets. The patients will be randomized in a 1:1 ratio by neutral researcher using sealed envelopes methods with assignment codes into the following two groups: Group I (Control group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo tablets twice daily for 3 months. Group II: (Diosmin group; n=30) which will receive mesalamine 1000 mg three times daily plus diosmin 600 mg twice daily for 3 months
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Drug: PlaceboGroup I (Control group; n=30) which will receive mesalamine 1000 mg three times daily plus placebo tablets twice daily for 3 months. |
| diosmin group | Experimental | Drug: DiosminGroup II: (Diosmin group; n=30) which will receive mesalamine 1000 mg three times daily plus diosmin 600 mg twice daily for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years old.
- Both male and female sex.
- Newly diagnosed patients with mild and moderate ulcerative colitis and treated with 5-aminosalicylic acid (mesalamine).
Key exclusion criteria (10 listed)
- Patients with severe ulcerative colitis.
- Patients with colorectal cancer.
- Patients on rectal or systemic steroids.
- Patients on immunosuppressants or biological therapies.
- Patients with previously failed treatment with sulphasalazine.
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 |
|---|---|---|
| Placeboplacebo tablets twice daily | Drug | control group |
| DiosminAlso: diosimaxdiosmin 600 mg twice daily | Drug | diosmin group |
Primary outcome
the change in Truelove and Witt's classification.
Time frame: at baseline then after 3 months
the change in health related quality of life (HRQoL) questionnaire
Time frame: at baseline then after 3 months
1 secondary outcome
the change in the measured biological parameters (TNF alpha, MDA, caspase-3)
Time frame: at baseline then after 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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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.
tarek M mostafa, professor principal investigator
Tanta University
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 Ulcerative Colitis, 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 10 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 12 Apr 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. Some participants in this study may receive a placebo. 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 amira B ismail, master (00201142760505, amira7794.aa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change in Truelove and Witt's classification. (time frame: at baseline then after 3 months). The study lists 2 primary outcomes in all. 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 12 Apr 2023.