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) Understand the research purpose, be able to truthfully assess one's psychological condition and voluntarily cooperate, sign an informed consent form, voluntarily accept the treatment of this study, and the informed consent process complies with relevant GCP regulations. (5) willing to give up other treatment methods for insomnia during the intervention period, including drug therapy and assisted sleep therapy
Exclusion criteria
Exclusion criteria: (1) Secondary insomnia and environmental sleep disorders caused by physical illnesses or symptoms of mental disorders. (2) Due to work reasons, the circadian rhythm is reversed. (3) The patient's concomitant medication contains sleep disrupting components such as olanzapine and chlorpromazine. (4) Those who use other traditional Chinese medicine and traditional Chinese patent medicines and simple preparations for insomnia or non short-term sedative hypnotics, antidepressants and antianxiety drugs within one week. (5) Patients with mental illness, severe anxiety disorders, and depression (patients with a simplified version of the Depression Anxiety Stress Self Rating Scale score of severe depression or anxiety, with a score of = 21 on the depression scale and = 15 on the anxiety scale), as well as patients with suicidal tendencies (with a score of>5 on the suicidal tendencies scale, regardless of whether they meet other criteria), are excluded. (6) Cognitive impairment prevents participants from understanding the trial instructions, completing questionnaires, or providing informed consent, as well as from taking medication on time, poor compliance, or inability to adhere to follow-up. (7) Individuals addicted to alcohol or psychotropic drugs. (8) Combined with severe cardiovascular, respiratory and other systemic diseases, malignant tumors or neurological disorders, or a history of severe traumatic brain injury. Abnormal liver and kidney function (AST, ALT>1.5 times the upper limit of normal reference values, SCr exceeding the upper limit of normal range), as well as clinically significant ECG abnormalities. (9) Pregnant and lactating women. (10) Patients who have participated in other clinical trials within the past 3 months. (11) Known to be allergic to the drugs used in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSQI; | — |
Secondary
| Measure | Time frame |
|---|---|
| TCM syndrome score;ISI;sleep diary;FatigueSeverityScale,FSS;Epworth Sleepiness Scale,ESS;Depression Anxiety and Stress Scale, DASS-21; | — |
Countries
China
Contacts
Public ContactLi Qiuyan
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed