Insomnia with deficiency of heart and spleen
Conditions
Interventions
research group:This study does not limit the patients' treatment regimen all enrolled patients were treated with Guipi capsule alone or in replacement or combination with current treatment regimen.0.3
Sponsors
Zhongda Hospital Southeast University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for insomnia in the International Classification of Sleep Disorders (3rd edition) (ICSD-3); (2) Meet the relevant diagnostic criteria in the "Clinical Practice Guidelines for Insomnia in Chinese Medicine" and belong to the syndrome of deficiency of the heart and spleen; (3) 18 years old = age = 75 years old gender is not limited; (4) Patients who agree to accept the use of Guisheng Capsules alone or in replacement or combination with the current treatment regimen; (5) Good compliance voluntary participation in the study and signing of informed consent.
Exclusion criteria
Exclusion criteria: (1) Pregnant or lactating women; (2) Patients with external fever and internal heat manifestations such as thirst yellowish urine and constipation; (3) Subjects who are unable to understand and complete the content of the relevant scale due to language visual or intellectual disabilities; (4) Subjects with comorbid serious mental illness (e.g. schizophrenia mood disorder) serious liver and kidney function impairment; (5) Subjects with active malignant neoplastic disease; (6) Subjects who are allergic to any component of the drug in this trial; (7) Participation in any other clinical trial currently or within the past 1 month; (8) Subjects who have used a reversionary product in the 1 month prior to enrollment; (9) Unsuitable for participation in this study as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSQI; | — |
Secondary
| Measure | Time frame |
|---|---|
| PSG;WHOQOL-BREF;PSQI;PHQ-9;ISI;Chinese Medicine Points Scale; | — |
Countries
China
Contacts
Public ContactYonggui Yuan
Zhongda Hospital Southeast University
Outcome results
None listed