insomnia
Conditions
Interventions
Control group:Right zopiclone tablets (3mg each time once daily)
experimental group:Guipi Capsules (4 capsules each time 3 times a day) combined with Dexmedetomidine Tablets (3mg each time 1 time a day)
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co. Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Participants must meet all of the following inclusion criteria: (1) Meets the diagnostic criteria for insomnia (DSM-V); (2) Screening period and baseline Pittsburgh Sleep Quality Index (PSQI) total score = 7 points; (3) Traditional Chinese Medicine (TCM) syndrome differentiation is based on the deficiency of both the heart and spleen; (4) Age between 18 and 70 years old (including 18 and 70 years old) gender is not limited; Voluntarily participate in this clinical trial and sign an informed consent form.
Exclusion criteria
Exclusion criteria: Any of the following cannot be included in the group: (1) History of other sleep disturbances: narcolepsy circadian sleep disorder sleepwalking sleep related respiratory disorders obstructive or central sleep apnea syndrome restless leg syndrome etc; (2) Patients must regularly take sleep aids or health supplements (except for dexmedetomidine tablets); (3) Within the past year there has been a severe mental illness or emotional disorder (such as anxiety depression suicidal tendencies or a history of suicide) or long-term use of central nervous system depressants or stimulants; (4) Other causes of insomnia in the past month such as pain fever cough surgery external environmental interference or stressful life events; (5) When screening the Hamilton Anxiety Scale score is = 14 points or the Hamilton Depression Scale score is = 17 points; (6) Within the past month or during the experimental phase there may be work and life behaviors such as shifting shifts and crossing three or more time zones; (7) Liver function ALT and AST exceed the upper limit of normal reference values by 1.5 times or Scr exceeds the upper limit of normal reference values; (8) Combining severe cardiovascular lung liver kidney endocrine or central nervous system diseases; (9) After treatment with antihypertensive drugs hypertensive patients have a systolic blood pressure greater than 160mmHg and/or a diastolic blood pressure greater than 100mmHg; (10) Drug and alcohol abuse or dependence; (11) Known to be allergic or ineffective to the investigational drug or its components; (12) Pregnant or lactating women women of childbearing age who cannot take contraceptive measures during the trial period; (13) Participated in clinical trials of other drugs within the past month; The researchers believe that it is not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Symptom Score;Sleep diary;Pittsburgh Sleep Scale Scale Factor Score; | — |
Countries
China
Contacts
Public ContactMinghua Wu
Jiangsu Province Hospital of TCM
Outcome results
None listed