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临床试验/ITMCTR2100004302
ITMCTR2100004302招募中1 期

Observation on Qingre Tongluo recipe in the treatment of difficult-to-treat rheumatoid arthritis with heat syndrome and its effect on drug resistance gene

Yunnan Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of traditional 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
招募中
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional study

入排标准

年龄范围
18 至 70(—)
性别
All

入选标准

  • 1. Normal group
  • (1)Age 18 ~ 70 years, gender is not limited;
  • (2)denial of history of rheumatoid arthritis and history of immune diseases;
  • (3)no relevant history of severe acute and chronic diseases;
  • (4)informed consent, voluntary test.
  • 2. The initial untreated group
  • (1)In line with the diagnostic criteria of RA Western medicine, and damp-heat obstruction syndrome of TCM diagnostic criteria;
  • (2)aged 18-70 years, gender;
  • (3)initial diagnosis without anti-RA drug treatment;
  • (4)the disease was active, DAS28 > 2.6.
  • 3. Effective treatment group
  • (1)In line with RA western medicine diagnostic criteria, 1995 ACR20 treatment effective standard, and damp-heat obstruction syndrome of TCM diagnostic criteria;
  • (2)aged 18 – 70 years, gender unlimited;
  • (3)patients who were treated with DMARDs for more than half a year without using biological agents and hormones, were in remission, did not affect normal learning and work, and could take care of themselves;
  • (4)DAS28 <= 2.6;
  • (5)Sign informed consent, voluntary test.
  • 4. Refractory group
  • (1)In line with RA western medicine diagnostic criteria, as well as damp-heat obstruction syndrome of TCM diagnostic criteria;
  • (2)aged 18 – 70 years, gender unlimited;
  • (3)patients who received regular application of two or more DMARDs for more than half a year were ineffective, and the disease was still active, unable to study and work normally, or even had difficulties in self-care;
  • (4)DAS28 > 3.2;
  • (5)patients whose symptoms did not meet the ACR20 remission standard;
  • (6)sign informed consent, voluntary test.

排除标准

  • (1) Patients who do not use the medicine according to the regulations cannot cooperate;
  • (2) Pregnant or lactating women;
  • (3) People who are currently infected with bacteria or viruses, or who are mentally or legally disabled; People with allergies or allergies to drugs such as methotrexate;
  • (4) Patients participating in other clinical trials;
  • (5) Patients with severe heart, liver and kidney dysfunction and accompanied by other malignant tumors;
  • (6) Those who have used biological agents and hormones within the last 3 months.

研究者

发起方
Yunnan Hospital of Traditional Chinese Medicine/The First Affiliated Hospital of Yunnan University of traditional Chinese Medicine

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