insomnia
Conditions
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) the subjects aged 18 to 65 years old (including boundary value), or female. (2) in accordance with above of traditional Chinese medicine, western medicine diagnosis standard and standard. (3) the total scores of PSQI > 7 points. (4) the research of treatment, the process of informed consent in conformity with the relevant provisions of the GCP. And (5) willing to give up other treatment methods for insomnia during the intervention period, including drug therapy and assisted sleep therapy Treatment and so on. Understand the purpose of the study, be able to trutily assess their own psychological status and voluntarily cooperate, sign informed consent, and voluntarily accept this treatment.
Exclusion criteria
Exclusion criteria: Anyone who has any of the following is excluded: (1) for the body disease or disorder symptoms caused by secondary insomnia and environments such as sleep disturbance and so on. (2) because working reason circadian rhythm. (3) The components of combined medication affecting sleep (such as olanzapine, clozapine, etc.). (4) use of other traditional Chinese medicine, Chinese patent medicine or non-short-acting sedatives and hypnotics for insomnia within one week; and Patients with antidepressant and anxiolytic drugs. (5) patients with psychosis, severe anxiety and depression (depression-anxiety-stress self-rating scale short form) For patients with severe depression and anxiety, the score of depression subscale was =21; Evaluation in anxiety subscales Score =15), and patients with suicidal tendencies (Suicide Tendency Rating Scale score > 5, regardless of whether or not) Other conditions were excluded). (6) Cognitive impairment that prevented subjects from understanding trial instructions, completing questionnaires, or providing informed consent Failure to take medication on time, poor compliance or adherence to follow-up were also noted. (7) alcohol addiction or psychotropic drug dependence. (8) complicated with serious cardiovascular, cerebrovascular, respiratory and other systemic diseases, malignant tumors or nervous system diseases Or a history of severe traumatic brain injury. Abnormal liver and kidney function (AST, ALT > 1.5 times normal reference value Upper limit, SCr exceeding the upper limit of the normal range), and clinically significant ECG abnormalities. (9) pregnant and lactating women. (10) patients who participated in other clinical trials within the past 3 months. This institute (11) are known to use drug allergies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rates calculated based on the Pittsburgh Sleep Quality Index scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| ISI;TCM syndrome score;sleep diary;Depression Anxiety and Stress Scale, DASS-21; | — |
Countries
China
Contacts
Public ContactLi Qiuyan
xiyuan hospital,chinese academy of traditional chinese medicine
Outcome results
None listed