Chronic insomnia
Conditions
Interventions
Experimental group:Yi An Ning pills, specifications: 3.1g / 18 pills, oral, 18 pills each time, 2 times a day, fatigue granule simulater, specifications 6 g / bag, boiled water, 2 bags each time, 2 ti
Control group:Yi An Ning pill simulating agent, specifications: 3.1 g / 18 pills, oral, 18 pills each time, 2 times a day, fatigue granules, specifications 6 g / bag, boiled water, 2 bags each time, 2
Sponsors
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for chronic insomnia in Western medicine; 2. Meet the diagnostic criteria of TCM sleeplessness (deficiency of qi and blood and evidence of insufficient liver and kidney); 3. Aged 18 - 65 years; 4. The cumulative score of the 7 components of the Pittsburgh Sleep Quality Index (Annexes I and II) > 7 points, and the Severity of Insomnia Index (ISI) score > 7 points; 5. The subject has informed consent, voluntarily accepted the test and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. In the past 1 month or during the experimental stage, there will be work life behaviors such as shift shifts and crossing 3 or more time zones; 2. Secondary insomnia (insomnia related to other mental disorders, sleep disorders due to internal medicine diseases - insomnia type, substance-caused sleep disorders - insomnia type), environmental sleep disorders, etc.; 3. Other sleep disorders: obstructive sleep apnea syndrome (OSAS), restless legs syndrome; 4. The Hamilton Depression Scale (Annex III) >= 17 points and the Hamilton Anxiety Scale (Annex IV) >= 14 points; 5. Use any other traditional Chinese medicine and proprietary Chinese medicine or non-drug treatment measures or non-short-acting sedative hypnotic drugs and antidepressants and anti-anxiety drugs within one week to treat insomnia; 6. Pregnant, lactating women or those who are unwilling to take contraception during the trial period and within 1 month after the end of the test; 7. Have a serious primary heart, liver, lung, kidney, blood or serious diseases that affect their survival, such as tumors or AIDS; abnormal liver and kidney function ALT, AST >= the upper limit of normal values is 1.5 times, and Cr > the upper limit of normal values; 8. Suspected or indeed have a history of alcohol or drug abuse; 9. Those who are unable to cooperate with physical or mental illness (such as blindness, deafness, muteness, intellectual disability, mental disorder, etc.); 10. Allergic constitution, such as a history of allergies to two or more drugs or foods; 11. Those who have participated in clinical trials of other drugs in the past 1 month; 12. Other factors that the investigator or assistant investigator determines are not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index, PSQI; | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective sleep efficacy (subjective sleep latency, subjective total sleep time, subjective sleep arousal times, subjective sleep arousal time);Insomnia severity index, ISI;fatigue severity scale, FSS;TCM symptom score; | — |
Countries
China
Contacts
Public ContactLi Bin
Outcome results
None listed