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临床试验/NCT00508729
NCT00508729Unknown2 期

Effect of Traditional Chinese Medicine on Gastrointestinal Function Recovery and Nutrition Support in Severe Acute Pancreatitis

Tianjin Nankai Hospital12 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2007年10月最近更新:
适应症
相关药物

试验速览

阶段
2 期
入组人数
300
试验地点
12
主要终点
Mortality

研究概览

简要总结

With multicenter randomized control clinical evaluation investigations, the effect of traditional Chinese medicine on gastrointestinal function recovery and nutrition support in early stage of severe acute pancreatitis (SAP) was evaluated, and the therapeutic effects, safety and indications assured. Drawing in latest research fruits at home and abroad, a clinical practical guideline would be formed, to be popularized all over China.

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

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

入选标准

  • Adult patients 18 yr-70 yr
  • Complying with the diagnostic standard of acute pancretitis (clinical symptoms and signs, elevated blood and urine amylase, and imaging criteria)
  • Conforming to 3 or more Ranson's criteria and APACHE-II score larger than 8, Balhazar CT score larger than 5

排除标准

  • Pregnancy
  • Nursing mother
  • Critical cases of advanced tumor
  • On the verge of death (estimated to be moral in 12h)
  • Severe visceral function disturbance
  • Patients undergoing other therapeutic research that might interfere with the present study

结局指标

主要结局

Mortality

时间窗: endpoint of the trial

Morbidity

时间窗: endpoint of the trial

Hospitalization days

时间窗: endpoint of the trial

Total expenses

时间窗: endpoint of the trial

次要结局

  • G-I tract function: nature of abdominal pain, intra-abdominal pressure, number of bowel movements(The above criteria should be tested on admission, and 24h, 48h and 72h later, 5d, 7d, and 2wks after admission, and on the day of discharge)
  • Parameters of nutrition(The above criteria should be tested on admission, and 24h, 48h and 72h later, 5d, 7d, and 2wks after admission, and on the day of discharge)

研究者

申办方类型
Other

研究点 (12)

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