Clinical Study to Evaluate the Possible Efficacy and Safety of Empagliflozin in Patients With Ulcerative Colitis
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- clinical improvement of patients of mild to moderate UC using using the Montreal classification of severity of ulcerative colitis.
研究概览
简要总结
•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.
详细描述
- It will be conducted on 60 patients having with mild to moderate degree UC divided into two groups:
- Group 1 (n=30): Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid).
- 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
- Complete blood picture (CBC).
- Liver functions (ALT, AST, Total and Direct Bilirubin).
- Kidney functions tests (Urea, serum creatinine).
- C-reactive protein.
- Fasting blood glucose.
- Urine analysis. B) Specific Laboratory tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double blinded study
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderate UC are diagnosed by history, clinical signs according to the Montreal classification of severity of ulcerative colitis and( Endoscopy, and biopsy) to establish the chronicity of inflammation and to exclude other causes of colitis.
排除标准
- •Other inflammatory bowel diseases (CD).
- •History of serious hypersensitivity to empagliflozin or any component of the formulation.
- •Patients on dialysis.
- •Severe renal impairment (eGFR <20 ml/minute/1.73m2) .
- •Chronic urinary tract infection.
- •Chronic genital infection.
研究组 & 干预措施
placebo group
Patients will receive conventional treatment only (corticosteroids +immune suppressive +amino salicylic acid) for 4 months.
干预措施: conventional treatment (Drug)
empagliflozin group
Patients will receive conventional treatment (corticosteroids +immune suppressive + aminosalicylic acid) and empagliflozin (0.4 - 0.5mg/kg/day) orally (maximum dose 25mg per day)for 4months.
干预措施: Empagliflozin (Drug)
结局指标
主要结局
clinical improvement of patients of mild to moderate UC using using the Montreal classification of severity of ulcerative colitis.
时间窗: 4months
difference between the two groups in (number of stool per day+prescence of fever +present of systemic toxicity+hemoglibin +ESR)
次要结局
- expression of TNFalpha(4months)
- expression of Adenosine monophosphate activated protein kinase (AMPK ).(4months)
- expression of Fecal calprotectin(4months)