跳至主要内容
临床试验/CTRI/2024/03/064590
CTRI/2024/03/064590尚未招募3 期

To study the efficacy of oral corticosteroid compared to intravenous corticosteroid as a first line therapy for treatment of Acute severe ulcerative colitis. - NI

PGIMER0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
PGIMER

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Diagnosed cases of UC by endoscopy and biopsy
  • 2. Patients with acute severe ulcerative colitis

排除标准

  • 1. Patients with Hb less than 8g/dl
  • 2. Patients with serum albumin levels less than 2.5 g/dl
  • 3. Patients with sepsis precluding the use of corticosteroids with any two of the three criteria Fever Temp more than 100 F, TLC less than 4000/cumm or more than 12000/cumm, raised procalcitonin (more than 1 pg/dL)
  • 4. Patients having more than 10 blood mixed stools
  • 5. Patients having megacolon or toxic megacolon on abdominal x-ray
  • 6. Patients with abdominal tenderness or features of impending perforation
  • 7. Patients who have had any flare requiring corticosteroids in the preceding 3 months from inclusion
  • 8. Patients with prior history of failure of response to intravenous corticosteroids for severe flare of ulcerative colitis
  • 9. Patients already receiving oral corticosteroid at the time of inclusion
  • 10. Patient who have received more than 1 dose of IV Corticosteroid during index admission
  • 11. Poor performance status (ECOG 3)
  • 12. Patients with suspected or proven malignancy of any organ and GI malignancy
  • 13. Inclusion any other drug trial in last 03 months affecting outcome of current trial
  • 14. Not willing to participate in the trial and sign the informed consent
  • 15. Pregnant and lactating females
  • 16. Patients with prior colonic surgery due to any cause.

研究者

发起方
PGIMER

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