insomnia
Conditions
Interventions
Group 1:Rougan Jiaoxin Granule (high dose)
Group 2:Rougan Jiaoxin Granule (low dose)
Group 3:Rougan Jiaoxin Granule placebo
Sponsors
Dongfang Hospital,Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of insomnia in ICD-11 standard of western medicine; 2. Meet the syndrome standard of deficiency of liver blood with hyperactivity of heart-liver fire in traditional Chinese medicine; 3. 18 years old 7 points; 6. Stable vital signs, clear consciousness, no communication and cognitive impairment, able to cooperate with scale assessment and wearable sleep monitoring device users; 7. Subjects sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with other types of sleep disorders {including severe daytime sleepiness (ESS>16), respiratory related sleep disorders, restless leg syndrome, periodic limb movement disorders, etc.}; 2. Patients with definite diagnosis of anxiety or depression, HAMD-17=17 points or HAMA=14 points; 3. Insomnia caused by other mental disorders; 4. Insomnia caused by head trauma, central nervous system diseases (including dementia, parkinson's disease, etc.) or other system diseases; 5. Alcohol, drugs, drug addicts; 6. Systemic diseases include pain, fever, surgery, and external factors that cause insomnia; 7. Patients complicated with tumor or serious organic diseases such as heart, brain, lung, liver and kidney; 8. Clinical trials of other drugs are ongoing, or clinical trials have been conducted within 1 month or 5 half-lives (whichever is longer) prior to screening; 9. Pregnant and lactating women; 10. Allergy or a history of hypersensitivity to the components of the test preparation; 11. Patients who regularly take sleep aids or supplements; 12. In the experimental stage in the past 1 month, there may be shift work, spanning 3 or more time zones to work and live; 13. Those who used chemical hypnotics 2 weeks before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Interview; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Interview 7 sub-items;Insomnia Severity Index;Hamilton Anxiety Scale;Hamilton Depression Scale;Traditional Chinese Medicine symptom score;Wearable sleep monitoring device data;Sleep diary data;Permitted number/dose of sleep aids;?-aminobutyric acid;glutamate;5-hydroxytryptamine;dopamine; | — |
Countries
China
Contacts
Public ContactJin Xianglan
Dongfang Hospital,Beijing University of Chinese Medicine
Outcome results
None listed