Chronic insomnia (liver and kidney Yin deficiency, heart-liver fire-flourishing syndrome)
Conditions
Interventions
Test group:Nvzhen Granule orally, 6g/ time, 3 times/day, once in the morning, middle and evening
Control group:Nvzhen Granule simulation agent orally, 6g/ time, 3 times/day, once in the morning, middle and evening
Sponsors
Dongzhimen Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria of Western medicine for chronic insomnia,the diagnosis was made according to the diagnostic criteria for chronic insomnia in the Guidelines for the Diagnosis and Treatment of Insomnia in China (2017 edition) issued by the Sleep Disorder Group of the Neurology Branch of the Chinese Medical Association; (2) In line with traditional Chinese medicine sleepless diagnosis criteria and liver and kidney Yin deficiency, heart and liver fire Wang syndrome differentiation criteria,the standard refers to the TCM diagnosis standard of Wanmei (Non-organic insomnia) (Trial) of the State Administration of Traditional Chinese Medicine, and is formulated in combination with the key points of syndrome differentiation; (3) Age 18-70 years old, gender is not limited; (4) Pittsburgh Sleep Quality Index score > 7; (5) The subjects voluntarily take the test and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Other sleep disorders: such as obstructive sleep apnea syndrome (OSAS), restless leg syndrome, etc.; (2) Short-term insomnia patients; (3) Secondary insomnia (insomnia related to other mental disorders, sleep disorders caused by medical diseases - insomnia type, sleep disorders caused by substances - insomnia type), environmental sleep disorders, etc.; (4) Hamilton Depression Scale 17 points =17 points, Hamilton anxiety scale =14 points; (5) Use other Chinese medicine and proprietary Chinese medicine for insomnia within a week; (6) Use sedative hypnotic drugs and anti-depression and anti-anxiety drugs within one month; (7) Patients with severe primary diseases of the heart, liver, kidney, brain, digestive and hematopoietic systems and mental disorders, in which blood ALT and AST > 1.5 times the upper limit of normal, Tbil > 1.5 times the upper limit of normal, and blood creatinine (Scr) > the upper limit of normal; (8) Allergic to or allergic to any component of the investigational drug; (9) People who may use central excitatory or inhibitory drugs to treat symptoms or diseases such as dizziness before screening or during the trial; (10) Alcoholic or alcohol dependent persons; (11) Suicidal persons; (12) Pregnant and lactating female patients; (13) The subjects of reproductive age or their partners do not wish to use one or more non-drug contraceptive methods (such as total abstinence, condoms, contraceptive rings, ligation, etc.) during the trial; (14) Patients enrolled in other clinical trials within 3 months; (15) Other subjects deemed unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Scale (PSQI) (including sleep latency, subjective sleep quality, sleep persistence, habitual sleep efficiency, sleep disturbance, use of sleep medication, daytime dysfunction); | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index (ISI);Fatigue severity scale score;Curative effect of TCM syndrome;Sleep diary (mean subjective sleep latency, mean subjective sleep duration, mean subjective sleep quality, mean subjective sleep wake time, mean subjective sleep wake times);Hamilton Anxiety Scale (HAMA) score;Hamilton Depression Scale (HAMD) score;Polysomnography (PSG), latency to sleep (LPS), mean sleep duration (TST), sleep efficacy, sleep wake time (WASO), number of sleep wakefulness (NAW);Simple Intelligent Mental State Examination Scale (MMSE);The incidence of clinical adverse events / reactions;Physical examination;Vital signs (pulse, blood pressure, body temperature, breathing);Blood routine (RBC, HGB, WBC, PLT), urine routine, liver function (ALT, AST, ? -GT, Tbil, ALP), renal function (Skr, urea nitrogen / urea, UACR, urinary NAG enzyme, eGFR), fasting blood glucose;Routine 12-lead ECG;Benzodiazepine withdrawal Symptoms Questionnaire (BWSQ) scale; | — |
Countries
China
Contacts
Public ContactZhou Li
Dongzhimen Hospital, Beijing University of Chinese Medicine
Outcome results
None listed