Insomnia
Conditions
Interventions
experimental group:Shui'an Capsules, oral administration, 3 capsules at a time, 3 times a day, for a total of 4 weeks.
control group:Shui'an Capsules Placebo, oral, 3 capsules at a time, 3 times a day, for a total of 4 weeks.
Sponsors
Dongzhimen Hospital, Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meets Western medical diagnostic criteria and has a traditional Chinese medicine syndrome of heart and liver blood deficiency; (2) Age 18–80 years; (3) Pittsburgh Sleep Quality Index (PSQI) score =7 points; (4) Participants are voluntary and have signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Disruption of the circadian rhythm due to work-related reasons; (2) Secondary insomnia (insomnia associated with or caused by other diseases) and environmental sleep disorders, etc.; (3) Hamilton Depression Rating Scale (17-item) total score =17 points, Hamilton Anxiety Rating Scale total score =14 points; (4) Use of other traditional Chinese medicines, proprietary Chinese medicines, or non-short-acting sedative-hypnotic drugs, as well as antidepressants or anxiolytics within the past week; (5) Individuals with a tendency to bleed who are currently undergoing antiplatelet therapy; (6) Pregnant or breastfeeding women; (7) Those with severe primary heart, liver, lung, kidney, or blood system diseases, or severe diseases affecting survival; (8) Those with a history of suspected or confirmed alcohol or drug abuse; (9) Those with allergic constitutions, such as a history of allergies to two or more drugs or foods, or known allergies to any components of this medication; (10) Those who have participated in other drug clinical trials within the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine Syndrome Scoring Scale;Sleep Diary;The sleep tracker monitors sleep metrics;Frequency of taking Eszopiclone; | — |
Countries
China
Contacts
Public ContactRen Yi
Dongzhimen Hospital, Beijing University of Chinese Medicine
Outcome results
None listed