insomnia
Conditions
Interventions
treatment group:Shuhe Granules
control group:placebo
Sponsors
Guangdong Provincial hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-70 (2) In line with Western medicine chronic insomnia diagnostic standards It is consistent with the diagnostic criteria of chronic insomnia in the new edition of International Classification of Sleep Disorders? formulated by the American Academy of Sleep Medicine (3) Consistent with the indications of Shuhe granules: Both of the following three a. sleep difficulty factor score of Pittsburgh Sleep Quality Index =1 b. daytime function factor score of Pittsburgh Sleep Quality Index =1 c. Dizziness, palpitation, low menstrual volume, spontaneous sweating, fear of wind, cold limbs, white tongue, pale face, pale or reddish eyelids (symptoms =3/8). None of the following cannot appear at the same time a. The lower eyelid is completely red b. Warm hands c. Dry, stiff stool d. Thick and greasy or dry and rough moss e. Pulse ratio greater than 5.5 (4) Sign informed consent
Exclusion criteria
Exclusion criteria: 1.Preparing to become pregnant or during pregnancy or lactation; 2. Secondary insomnia caused by physical disease. For example: local pain, restless leg syndrome, sleep apnea syndrome, acute and chronic heart failure, chronic obstructive pulmonary disease, acute and chronic bronchitis, etc. 3. Secondary insomnia caused by mental disease. For example: Affective disorders, anxiety disorder, depression, schizophrenia, and any other serious mental disorders. 4. A Patient health questionnaire-9 (PHQ-9) score of 15 or higher; 5. A Generalized Anxiety Scale (GAD-7) score of 15 or higher 6. Use of medicine to treatment sleeping disorders in the past two week. 7.Participants in clinical trials of other drugs in the past 30 days;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;Patient health questionnaire-9;polysomnography;Fatigue Severity Scale;Traditional Chinese Medicine Questionnaire of Quality of life on Insomnia disease;Generalized Anxiety Scale-7; | — |
Countries
China
Contacts
Public ContactZhimin Yang
Guangdong Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed