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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.
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:
3 ml of blood will be used for immediate determination of routine parameters including:
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:
Clinical assessment will be done through determination of:
A. Disease severity which will be assessed according to the modified Truelove and Witt's classification.
B. 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.
C. Health-related Quality of Life (HRQoL) using The Short Inflammatory Bowel Disease Questionnaire (SIBDQ).
D. Assessement of pain score through the brief pain inventory short form "BPI-SF" worst item.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo tablets twice daily |
| |
| Diosmin |
| Measure | Description | Time Frame |
|---|---|---|
| the change in Truelove and Witt's classification. | at baseline then after 3 months | |
| the change in health related quality of life (HRQoL) questionnaire | at baseline then after 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| the change in the measured biological parameters (TNF alpha, MDA, caspase-3) | at baseline then after 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| amira B ismail, master | Contact | 00201142760505 | amira7794.aa@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| tarek M mostafa, professor | Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta university hospital | Recruiting | Tanta | Egypt |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004145 | Diosmin |
| ID | Term |
|---|---|
| D047309 | Flavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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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
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This proof of concept study will be designed to be a randomized, double-blind, placebo controlled parallel study, The blindness will be maintained by the similarity in appearance, color and shape between placebo and diosmin tablets.
| Drug |
diosmin 600 mg twice daily |
|
|
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |