Anhypnosis
Conditions
Sponsors
Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria of insomnia; 2. Patients who meet the diagnostic criteria of insomnia (Qi deficiency syndrome) in TCM; 3. Aged 45-75 years; 4. The cumulative score of 7 components of Pittsburgh sleep quality index was 5; 5. The subjects with informed consent were voluntary and signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Shift workers; 2. Subjects with secondary insomnia (insomnia related to other mental disorders, sleep disorders caused by medical diseases (insomnia), sleep disorders caused by substances (insomnia), environmental sleep disorders, etc.; 3. Patients with other sleep disorders: obstructive sleep apnea syndrome (OSAS), restless legs syndrome; 4. The score of Hamilton Depression Scale (HAMD) was more than 17, and the score of Hamilton Anxiety Scale (HAMA) was more than 14; 5. The subjects who use other traditional Chinese medicine or Chinese patent medicine or non short acting sedative hypnotics, antidepressants and anxiolytics to treat insomnia within one week; or the subjects who are receiving dual antiplatelet therapy or monoclonal antiplatelet therapy and are prone to bleeding; 6. Pregnant women and lactating women; 7. Patients with severe primary heart, liver, kidney, blood or other serious diseases affecting their survival have abnormal liver and kidney functions, ALT and AST >= 1.5 times of the upper limit of normal value, Cr > the upper limit of normal value; 8. Subjects with suspected or history of alcohol or drug abuse; 9. Subjects with allergic constitution, such as being allergic to two or more drugs or foods; 10. Subjects known to be allergic to drug components; 11. Subjects who participated in clinical trials of other drugs in recent 3 months.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| ISI score for insomnia severity index; | — |
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh and sleep quality Index score;Fatigue Severity Scale Score (FSS); | — |
Countries
China
Contacts
Public ContactZhang Jie
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed