wakefulness
Conditions
Interventions
Sponsors
Guang'anmen Hospital, China Academy of Chinese Medical Sciences.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 2. Those who meet the syndrome differentiation of TCM as Qi stagnation and blood stasis syndrome; 3. Sleep quality PSQI score > 7 points; 4. Insomnia Severity Index Scale score >= 8 points; 5. Insomnia symptoms appear more than 3 times a week for more than 1 month; 6. Persons aged 18 to 65 (including 18 and 65), regardless of gender; 7. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Insomnia caused by certain physical diseases, organic diseases of the brain, and drug reactions; 2. Insomnia caused by schizophrenia, depression, anxiety or other mental disorders; patients with HAMD score of 17 or more when enrolled; or total score of HAMA of 14 or more; 3. Sleep disorders due to poor sleep hygiene, jet lag syndrome, shift work, and other irregular work schedules; sleep apnea syndrome, narcolepsy, and typical insomnia caused by other sleep disorders such as night terrors and nightmares; 4. Combined liver and kidney damage, ALT, AST >= 1.5 times the upper limit of normal value, or Cr > the upper limit of normal value; combined with serious primary diseases such as hematopoietic system; 5. Drug or alcohol dependent persons; 6. People with allergies or allergies to this drug; 7. Poor blood glucose control; 8. Pregnant or intended pregnant or lactating women; 9. Have used sleeping pills, antidepressants, anti-anxiety drugs or other drugs that affect the central nervous system in the last two weeks or psychological and physical therapy; 10. Participants in other clinical trials in the past 3 months; 11. Researchers consider others unsuitable for participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index Scale (ISI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI);TCM individual symptoms;The effects of individual symptoms;PDQ-4 scale;PHQ-9 scale;GAD-7 scale;PHQ-15 scale; | — |
Countries
China
Contacts
Public ContactJian Wang
Outcome results
None listed