The clinical efficacy research and Intestinal flora of Wu-Mei-Wan Decoction in treatment of early awakening insomnia
- Conditions
- early awakening insomnia
- Registration Number
- ITMCTR2000003357
- Lead Sponsor
- inyi City People's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(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.
(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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PSQI;Quality of life scale of traditional Chinese Medicine;intestinal flora;
- Secondary Outcome Measures
Name Time Method