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临床试验/ITMCTR2000003357
ITMCTR2000003357尚未招募1 期

The clinical efficacy research and Intestinal flora of Wu-Mei-Wan Decoction in treatment of early awakening insomnia

inyi City People's Hospital0 个研究点开始时间: 待定最近更新:

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 study

入排标准

年龄范围
18 至 60(—)
性别
All

入选标准

  • (1) in line with the western medicine diagnostic criteria for insomnia
  • (2) in accordance with the clinical manifestations of early awakening: sleep awakening time than normal time above 30 min in advance, or wake up earlier than usual 1 ~ 2 h, the total sleep time is less than 6 h; Includes the following 1 to several items: extremities cold, apex pain, thirst, hunger, restlessness and restlessness.
  • (3) the total PSQI score was > and 7;
  • (4) between the ages of 18 and 60, both male and female;
  • (5) to understand the clinical observation significance of this drug, actively cooperate with the clinical follow-up and clinical evaluation of the researchers engaged in this drug, and have good compliance;
  • (6) patients voluntarily participate in this study with full knowledge;
  • (7) drugs that damage liver and kidney functions have not been applied within 3 months;
  • (8) denied participating in other treatments within 3 months;
  • (9) have not taken any sedatives within one week;
  • (10) those who are conscious, agree and able to cooperate in collecting clinical data.

排除标准

  • (1) patients with insomnia who complained of multiple dreams and impaired shallow social function;
  • (2) excluding secondary insomnia: insomnia caused by systemic diseases such as pain, fever, cough, surgery, external interference, etc., as well as insomnia caused by physical diseases or mental disorders, such as depression; Anxiety disorder; People with mental illness;
  • (3) patients with serious primary and serious organic diseases including heart, cerebrovascular, lung, liver, kidney and hematopoietic system;
  • (4) patients with allergic constitution;
  • (5) women during pregnancy and lactation;
  • (6) patients with alcohol and drug dependence and substance abuse;
  • (7) patients with decompensated respiratory dysfunction, myasthenia gravis and severe sleep apnea.

研究者

发起方
inyi City People's Hospital

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