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临床试验/ITMCTR2024000025
ITMCTR2024000025尚未招募1 期

Evaluation of the efficacy and mechanism of New Wumei Pill in the treatment of mesalazine-refractory ulcerative colitis

Dongfang Hospital, Beijing University of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症

试验速览

阶段
1 期
状态
尚未招募
发起方

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

年龄范围
18 至 65(—)
性别
All

入选标准

  • (1)The participants must meet the diagnostic criteria of mildly to moderately active ulcerative colitis.
  • (2)The participants have taken standard doses of 5-ASA continuously for more than 6 weeks or more.
  • (3)TCM syndrome type belongs to damp-heat stasis and spleen-kidney Yang deficiency.
  • (4)Their ages are between 18 and 65.
  • (5)The participants volunteer for this clinical trial and sign informed consents.

排除标准

  • (1)Severely active UC.
  • (2)Pregnancy, lactation or preparing for pregnancy.
  • (3)Severe allergy or allergic to mesalazine or any of the ingredients in New Wumei Pill.
  • (4)Serious cardiovascular and cerebrovascular disease (chronic heart failure with New York Heart Association heart function above class ?, severe arrhythmia and severe stroke sequelae). Severe primary diseases of liver, kidney and hematology and so on.
  • (5)Serious complications, such as intestinal stenosis, intestinal obstruction, intestinal perforation, multiple intestinal polyps, toxic megacolon or colorectal cancer, etc.
  • (6)Mental and intellectual disabilities.
  • (7)Have participated in other medical clinical studies in the last 3 months.
  • (8)Receive other treatments for ulcerative colitis other than mesalazine.

研究者

发起方
Dongfang Hospital, Beijing University of Chinese Medicine

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