chronic insomnia
Conditions
Interventions
Group 1 :Liuwei Anshen capsule + zopiclone simulant
Group 2:Liuwei Anshen capsule simulant + zopiclone tablets
Group 3:Liuwei Anshen capsule + zopiclone tablets
Sponsors
Oriental Hospital of Beijing University of traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria of chronic insomnia in western medicine and insomnia in traditional Chinese medicine with syndrome of yin deficiency and hyperactivity of fire with phlegm; 2. 5 points <= PSQI <= 16 points; 3. 18 years old <= age <= 65 years old; 4. Those who can cooperate with the completion of various scale assessments, blood tests and sample collection; 5. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Mini scale interview prompts mentally handicapped persons; 2. Patients with substance use disorders (including alcohol, tobacco, caffeine, sedatives, psychoactive drugs and other substance addiction or abuse); 3. SQ >= 5 points; SBQ >= 3 points; IRLS >= 10 points; 4. Antidepressants and other psychotropic drugs have been used within the past 2 weeks (fluoxetine has been used within 4 weeks); 5. During the course of treatment, any drugs that can improve sleep (including traditional Chinese medicine or health care products with tranquilizing effect) are used in combination; 6. Pregnant, lactating, and pregnant women; 7. HAMA >= 14 points; HAMD (17 items) >= 17 points; 8. Those who are allergic to the experimental drugs and ingredients, those who have participated in clinical trials in the past 3 months, and those who are considered by the researchers to be unsuitable to participate in this trial; 9. Severe primary heart, liver, lung, kidney, blood or serious diseases that affect their survival, such as tumor or AIDS (ALT is 1.5 times higher than normal, creatinine is higher than normal; abnormal electrocardiogram with clinical significance; White blood cells < 3.0 x 10^9/L).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Interview; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale;Hamilton Anxiety Scale;Insomnia Severity Index;Epworth Sleepiness Scale;Traditional Chinese Medicine symptom score;Intestinal barrier permeability marker: Zonulin;Blood-brain barrier permeability marker: S100ß;Interleukin-1ß;Interleukin-6;Tumor necrosis factor alpha;Interleukin-4;Interleukin-10;?-aminobutyric acid;5-hydroxytryptamine;Norepinephrine;cortisol;Intestinal flora 16S;Macrogene sequencing of intestinal flora;Serum targeted short chain fatty acid metabolome; | — |
Countries
China
Contacts
Public ContactGuo Rongjuan
Dongfang Hospital Beijing University of Traditional Chinese Medicine
Outcome results
None listed