Chronic Insomnia in the Elderly
Conditions
Interventions
Control group:Melatonin
Experimental group:Heart-Kidney Harmonizing Formula
Sponsors
Tongchuan Hospital of Traditional Chinese Medicine(Sun Simiao Hospital Beijing University of Chinese Medicine)
Eligibility
Sex/Gender
All
Age
60 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meet the Western medical diagnostic criteria for chronic insomnia;(2) Meet the diagnostic criteria for chronic insomnia with Heart-Kidney Disharmony Syndrome in Traditional Chinese Medicine (TCM);(3) Aged 60 to 75 years regardless of gender;(4) Pittsburgh Sleep Quality Index (PSQI) score = 7;(5) Possess sufficient cognitive ability to understand relevant scales;(6) Voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with secondary insomnia caused by other physical diseases mental illnesses or external interference factors;(2) Patients diagnosed with moderate to severe anxiety or depression based on anxiety and depression scales;(3) Patients with severe underlying diseases including but not limited to cardiac pulmonary renal gastrointestinal hematological neuropsychiatric immunological metabolic malignant tumors or severe malnutrition;(4) Patients who are unable to cooperate due to their mental state such as those with psychiatric disorders lack of insight or inability to express themselves clearly;(5) Patients allergic to the products involved in the treatment regimen;(6) Individuals deemed unsuitable for using the drugs involved in the treatment regimen according to the investigators judgment (e.g. those who have taken Western sedative-hypnotic medications within the past week);(7) Individuals currently participating in other interventional clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| TCM Syndrome Score;Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Measure Yourself Medical Outcomes Profile;Epworth Sleepiness Scale; | — |
Countries
China
Contacts
Public ContactXiaohong Gu
Beijing University of Chinese Medicine
Outcome results
None listed