Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT05610956
Brief Summary:
•This study will be a randomized, controlled, parallel study. .To demonstrate the efficacy of empagliflozin and clinical improvement in patients of mild to moderate UC using the Montreal classification of severity of ulcerative colitis.
Detailed Description:
* It will be conducted on 60 patients having with mild to moderate degree UC divided into two groups:
1. Group 1 (n=30): Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid).
2. Group 2 (n=30): Patients will receive conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid) and empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day).
* The patient will be selected from the Gastroenterology and Endoscopy Unit, Internal Medicine.
. All patients will be subjected to the following:
* Complete history taking.
* Colonoscopy with intubation of the ileum and biopsies of affected and unaffected areas should be obtained to confirm the diagnosis of UC.
* Blood sample collection to assess:
A) Routine Laboratory tests
1. Complete blood picture (CBC).
2. Liver functions (ALT, AST, Total and Direct Bilirubin).
3. Kidney functions tests (Urea, serum creatinine).
4. C-reactive protein.
5. Fasting blood glucose.
6. Urine analysis. B) Specific Laboratory tests
1\. Tumor necrosis factor alpha (TNF-α). 2. Adenosine monophosphate activate protein kinase (AMPK). 3. Fecal calprotectin. All patients will be assessed at baseline and after 4 months of therapy for all parameters
Study:
NCT05610956
Study Brief:
Protocol Section:
NCT05610956