chronic insomnia
Conditions
Interventions
treatment group:Shuhe Granule
Sponsors
Guangdong Provincial Hospital of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) The men and women patients are aged 18–65 years. (2) Patients who meet the diagnostic criteria for insomnia based on the International Classification of Diseases 11th Revision. 15 (3) Patients who meet the deficiency of heart and kidney disorder of qi and blood syndrome. (4) Patients who volunteer to participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Meet two of the excluded symptoms a. Red lower eyelids. b. Feverish hands. c. Dry and hard stool. d. Thick and slimy fur or dry and coarse fur. e. The pulse-to-respiration ratio is greater than 5.3. (2) Patients who are pregnant lactating or plan to become pregnant and with known mental disorders. (3) Based on the medical history and consultation the doctor confirmed that secondary insomnia was caused by other diseases. For example: local pain restless legs syndrome sleep apnea syndrome (apnea-hypopnea index AHI ? 15/h) acute or chronic heart failure chronic obstructive pulmonary disease acute or chronic bronchitis etc. (4) Patients with severe depression [Patient Health Questionnaire 9 (PHQ-9) = 15 score]. (5) Patients with severe anxiety [Generalized Anxiety Disorder 7 (GAD-7) = 15 score]. (6) Patients with severe insomnia [Insomnia Severe Index (ISI) = 22 score]. (7) Patients participating in other clinical trials within 4 weeks of the screening period. (8) Patients with hemoglobin level less than 90
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ISI; | — |
Secondary
| Measure | Time frame |
|---|---|
| GAD-7;TCMQLI-21;FSS;PSQI;PHQ-9;HRV;Biomagnetosensing; | — |
Countries
China
Contacts
Public ContactYang Zhimin
Guangdong Provincial Hospital of Traditional Chinese Medicine.
Outcome results
None listed