insomnia
Conditions
Interventions
Test group:Shuhe Granule,150ml each time with hot water, twice a day for 4 weeks
Sponsors
Guangdong Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) 18 -70 years old. (2) It meets the diagnostic criteria of ICSD-3 chronic insomnia disorder. (3) ISI total score >7 (4) Stable vital signs, clear mind, with a certain ability to express (5) Consistent with Qi and blood disharmony, heart and kidney deficiency syndrome: Sleeplessness, fatigue, fear of cold or wind, cold limbs, palpitations, dizziness, spontaneous sweating, less menstruation, light white lower eyelids or light white with red edges; (6) Those who are taking sedative hypnotics (=4 nights per week) (7) Sign informed consent
Exclusion criteria
Exclusion criteria: (1) Comply with any of the excluded symptoms: a. The lower eyelid is completely red b. Warm hands c. Dry, hard stool d. Thick and greasy fur or dry and rough e. Pulse ratio greater than 5 (2) People who are preparing to become pregnant or during pregnancy or breastfeeding or who need to sleep with their children. (3) Based on the medical history and consultation, the doctor confirms secondary insomnia caused by other diseases. For example: local pain, restless leg syndrome, sleep apnea syndrome, acute and chronic heart failure, chronic obstructive pulmonary disease, acute and chronic bronchitis (4) Patients diagnosed with major depression according to the Patient Depression Screening Scale (PHQ-9) (total score =15) (5) Diagnosis of severe anxiety according to the Generalized Anxiety Disorder Scale (GAD-7) (total score =15) (6) Patients with severe cardiovascular, cerebrovascular, liver, kidney and endocrine system diseases and unstable conditions (7) Those who have suffered from severe mental illness such as major bipolar disorder, schizophrenia, mental retardation, alcohol/substance abuse or dependence, and suicidal tendencies (8) Participants who have participated in other drug clinical trials within the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia severity index scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index;Patient Health Questionnaire-9;Generalized Anxiety Disorder Scale;Fatigue severity scale;Usage of western medicine; | — |
Countries
china
Contacts
Public ContactBiyun Xu
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed