insomnia
Conditions
Interventions
The cotrol group:placebo
The test group:Shuhe Granules
Sponsors
Guangdong Provincial Hospitai of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) 18 years old or older; (2) Meet the diagnostic criteria for chronic insomnia of International Classification of Diseases-11(ICD-11); (3) Meet the diagnostic criteria of Shuhe Granules: Cold or wind intolerance, daytime mental fatigue, palpitations or dizziness, pale lower eyelids or red at the edge of lower eyelids, low menstrual flow and cold hands; (4) Signed the informed consent form;
Exclusion criteria
Exclusion criteria: (1) Meet any criteria of the eliminating symptoms eliminating symptoms: a. The lower eyelid is completely red b. Hand baking heat c. The stool is dry and(or) hard d. The moss is thick or dry and rough e. The pulse-to-breath ratio is greater than 5 (2) People who are preparing to become pregnant or pregnant or breastfeeding, or who need to accompany their children to sleep; (3) According to the medical history and consultation, the doctor confirms that secondary insomnia caused by other diseases. For example: local pain, restless legs syndrome, sleep apnea syndrome, acute and chronic heart failure, chronic obstructive pulmonary disease, acute and chronic bronchitis, etc.; (4) Diagnosis of severe depression patients according to the Patient Health Questionnaire-9 (PHQ-9)(total score =15); (5) Diagnosis of patients with severe anxiety according to the Generalised anxiety disorder-7(GAD-7)(total score =15); (6) Those who have participated in clinical trials of other drugs in the past 30 days; (7) Patients with other mental illnesses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total socres of Insomnia Severity Index(ISI); | — |
Secondary
| Measure | Time frame |
|---|---|
| The total score of Fatigue Scale-14(FS-14);The total scores and the various scores of the Pittsburgh sleep quality index;The total score of the Patient Health Questionnaire-9 (PHQ-9);The total score of the Sleep Diary;The total score of the Generalised anxiety disorder-7(GAD-7); | — |
Countries
China
Contacts
Public ContactZhimin Yang
Outcome results
None listed