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
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
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