Effect of antioxidant supplementation on progression of pancreatic fibrosis

AIIMS1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2010年1月3日最近更新: 2011年5月18日

试验速览

阶段: Unknown
状态: 招募中
发起方: AIIMS
入组人数: 60
试验地点: 1
主要终点: Surrogate markers of pancreatic fibrosis: TGF-beta 1,PDGF, fibronectin and pro-collagen III

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomised control trial to see the effect of a combination of antioxidants for 3 months on markers of fibrosis in 80 patients of chronic pancreatitis.The primary outcome measures will be surrogate markers of fibrosis. The secondary outcome measures will be markers of oxidative stress and antioxidant levels.

研究设计

研究类型: Interventional
分配方式: Permuted block randomization, fixed
盲法: Not Applicable

入排标准

年龄范围: 18.00 Year(s) 至 60.00 Year(s)（—）
性别: All

入选标准

•All the treatment naïve patient with Chronic Pancreatitis.

排除标准

•1.Complications like pseudocyst, pancreatic abscess, pseudoaneurysm, pancreatic fistula 2.Comorbid conditions like liver diseases,renal failure,pulmonary fibrosis.
•3.Patient with adenocarcinoma of pancreas, acute on chronic pancreatitis.
•4.Pregnant and lactating female 5.Age less than 12 years 6.Inability to give informed consent.

结局指标

主要结局

Surrogate markers of pancreatic fibrosis: TGF-beta 1,PDGF, fibronectin and pro-collagen III

时间窗: at baseline and 3 months of intervention

次要结局

Markers of oxidative stress: TBARS, Serum SOD Marker of antioxidant capacity or defense: Total glutathione, Ferric Reducing Assay of Plasma (FRAP)(at baseline and 3 months after intervention)

研究者

发起方

AIIMS

申办方类型

Research institution and hospital

研究点 (1)

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