insomnia
Conditions
Interventions
Control group:placebo
Experimental group:Kuntai capsule
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1)Meeting the diagnostic criteria for insomnia disorder in the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5); (2)Women 40-60 years old; (3)The Pittsburgh Sleep Quality Index (PSQI)>7 and the Insomnia Severity Index (ISI) score of the insomnia severity index (ISI) is less than or equal to 21; (4)No sleep improvement drugs or health care products (including sedative hypnotics antidepressants anti-anxiety drugs Chinese patent medicines Chinese herbal decoctions etc.) were taken within one week before enrollment and no non-drug treatments for sleep improvement such as cognitive behavioral therapy for insomnia (CBT-I) music therapy acupuncture etc. were received; (5) Be able to read understand and follow research procedures. (6)Sign informed consent.
Exclusion criteria
Exclusion criteria: (1)The subjects with insomnia caused by systemic diseases (such as pain fever cough surgery etc.) and external environmental interference factors (2)The subjects had a history of other sleep-related conditions or were currently suspected of having: narcolepsy circadian rhythm sleep disorders sleepwalking sleep-related breathing disorders obstructive or central sleep apnea syndrome restless leg syndrome etc (3)The subjects had been diagnosed with schizophrenia anxiety disorder depression or other serious mental disorders; or had a family history of mental illness; Hamilton Depression scale (Hamilton's Depression Scale HAMD) -17 items score> 18 points Hamilton Anxiety scale (Hamilton Anxiety Scale HAMA)> 21 points; (4)Yang deficiency constitution such as fear of cold cold limbs loose stools and so on. (5)Daily naps of at least 1 hour per day and at least 3 days per week. (6)Subjects who have been diagnosed of uncontrolled cardiovascular lung liver kidney endocrine or nervous system diseases malignant tumors and are judged by researchers to be unsuitable for the trial or may affect sleep. (7)The subjects had a history of hypertension and poor blood pressure control (systolic> 160mmHg and/or diastolic> 100mmHg) after antihypertensive drug treatment (8)Participants had a history of suspected or confirmed of abuse or dependence on alcohol (average daily consumption of more than 720mL beer 90mL liquor or 300mL wine) or drug (9)Those who drink excessive amounts of tea coffee and/or caffeinated beverages (defined as more than 4 cups [about 500 mL/cup] of caffeinated beverages or more than 400 mg of caffeine per day) daily or those who habitually consume caffeinated beverages after 18:00 and are unwilling to give up caffeinated beverages after 18:00 during the study (10)Smokers or those who smoked more than 10 cigarettes a day in the three months prior to screening or who used tobacco products when they woke up at night (11)Postmenopausal syndrome subjects who are or will receive hormone replacement therapy after enrollment; (12)Pregnant women women planning to become pregnant nursing mothers women of childbearing age who do not want to take effective contraceptive measures during the trial; (13)The subjects were known to be allergic to the test drug and its components (14)The alanine transaminase (ALT) and aspartate aminotransferase (AST) of liver function exceeded 1.5 times the upper limit of normal reference value or serum creatinine (Scr) exceeded the upper limit of normal reference value (15)Participants who have participated in or are currently participating in other clinical trials within 1 month prior to randomization (16)Subjects who may require surgical treatment after enrollment (17)The researchers believe there are other circumstances that make subjects unsuitable in this clinical trial .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| The Clinical Global lmpressions scale-Change;Modified Kupperman (KMI);Hamilton's Depression Scale;Insomnia Severity Index;The Patient Global lmpressions scale-Change;Hamilton Anxiety Scale; | — |
Countries
China
Contacts
Public ContactShuqin Zhan
Xuanwu Hospital Capital Medical University
Outcome results
None listed