Insomnia (evidence of heart, liver and blood deficiency)
Conditions
Interventions
Experimental group:Tranquilizing pills, 1 sachet/time, 1 time/day, taken in the evening
Placebo group:Tranquility pill simulant, 1 sachet/time, 1 time/day, taken in the evening
Sponsors
Guangdong Province Hospital of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 ~ 60 years old (including 18 and 60 years old), gender is not limited; 2. Meet the diagnostic criteria for insomnia (DSM-V); 3. TCM differentiation is evidence of heart, liver and blood deficiency; 4. Total score of Pittsburgh Sleep Quality Index (PSQI) during the screening period and baseline >= 7 points; 5. Screening period and baseline insomnia severity index (ISI) score > 7 points; 6. Voluntarily participate in this clinical trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients must regularly take sleep aids or health care products; 2. Drugs that have been taken that affect sleep within 2 weeks before and/or during the introduction period; 3. Have other related medical history that affects sleep: narcolepsy, circadian rhythm sleep disorder, sleepwalking, sleep-related breathing disorders, obstructive or central sleep apnea syndrome, restless legs syndrome, etc.; 4. Have had a serious mental illness or emotional disorder (such as anxiety, depression, suicidal tendencies or a history of suicide) in the past 1 year, or long-term use of central nervous system depression or stimulant drugs; 5. Hamilton Anxiety Scale score >= 14 points at screening, or Hamilton Depression Scale score >= 17 points; 6. Work and life behaviors such as shift work and span 3 or more time zones in the trial stage in the past 1 month; 7. Other causes of insomnia in the past 1 month, such as pain, fever, cough, surgery, external environment interference or stressful life events; 8. Combined with serious cardiovascular, lung, liver, kidney, endocrine or central nervous system diseases; 9. Liver function ALT and AST exceed the upper limit of normal reference value by 1.5 times, or Scr exceeds the upper limit of normal reference value; 10. Systolic blood pressure > 160mm Hg and/or diastolic blood pressure > 100mm Hg after antihypertensive drug treatment; 11. drug and alcohol abuse or dependence; 12. Known allergy to the test drug or its ingredients; 13. Pregnant or lactating women, who cannot take contraception during the test; 14. Have participated in clinical trials of other drugs within the past 1 month; 15. The investigators did not consider it suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total Pittsburgh Sleep Quality Index (PSQI) score changed from baseline on day 29 of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The PSQI individual factor scores (including sleep latency, subjective sleep quality, sleep persistence, habitual sleep efficiency, sleep disturbance, sleep medication, daytime dysfunction) on day 29 of treatment changed from baseline;The total score of insomnia severity index (ISI) at days 15 and 29 of treatment was changed from baseline;The total score of sleep diary (mean subjective sleep incubation period, mean subjective sleep duration, mean subjective sleep quality, mean subjective sleep wake time, and average subjective sleep awakening times) on the 15th and 29th days of treatment were changed from baseline;Evaluation of daytime symptoms: the score on the day 29 ISI scale for the portion of the daytime symptoms (item 5) change from baseline;The number and percentage of TCM symptoms (clinical cure, effective and ineffective) on the 15th and 29th days of treatment;The total score of TCM symptoms on the 15th and 29th days of treatment was changed from the baseline;On the 15th and 29th days of treatment, the individual scores of TCM certificates were changed from baseline;The disappearance rate of single symptoms of TCM certificate on the 15th and 29th days of treatment;Polysomnography (PSG) detection: change from baseline in sleep onset latency (LPS), mean sleep duration (TST), sleep efficacy, time to wake (WASO), and number of sleep wakes (NAW) on day 29 of treatment (monitored by available centers); | — |
Countries
China
Contacts
Public ContactLi Yan
Guangdong Province Hospital of TCM
Outcome results
None listed