Insomnia Disorder
Conditions
Interventions
Zhenzhongdan:It was administered orally twice daily, 30 minutes after lunch and 1 hour before bedtime, 7 days per week for 4 weeks.
Eszopiclone:Eszopiclone was administered orally once daily at bedtime, at a dose of 3 mg, 7 days per week for 4 weeks.
Sponsors
Fujian University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
60 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1)Aged 60–80 years; 2)Meeting the diagnostic criteria for primary chronic insomnia according to the International Classification of Sleep Disorders, Third Edition (Text Revision) (ICSD-3-TR); 3)Meeting the diagnostic criteria for insomnia with heart–kidney disharmony according to traditional Chinese medicine; 4)Pittsburgh Sleep Quality Index (PSQI) score = 6 before treatment; 5)No treatment with sedative–hypnotics, antidepressants, antipsychotics, or sedative traditional Chinese medicines within 1 month prior to enrollment; 6)Right-handed; 7)Able to understand and cooperate with the study procedures, and voluntarily provide written informed consent.
Exclusion criteria
Exclusion criteria: 1)Patients with depression defined as a score = 9 on the Geriatric Depression Scale-15 (GDS-15); 2)Montreal Cognitive Assessment (MoCA) score 160 mmHg or diastolic blood pressure >100 mmHg after medication) or poor glycemic control (HbA1c >11%); 5)Hepatic or renal insufficiency (AST/ALT greater than twice the upper limit of normal; serum creatinine >10% above the upper limit of normal); 6)Presence of neurological diseases, such as stroke, dementia, Parkinson's disease, or chronic pain; 7)Allergy to the study medications; 8)Patients unsuitable for MRI scanning, such as those with metal implants (e.g., metal dentures, cardiac pacemakers) or claustrophobia; 9)Inability to complete the outcome assessments (e.g., severe aphasia, visual or hearing impairment, or illiteracy); 10)Participation in other clinical trials that may affect the results of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Epworth Sleepiness Scale;Fatigue Severity Scale;Hamilton Anxiety Rating Scale;Hamilton Depression Rating Scale;Montreal Cognitive Assessment;Trail Making Test Part B;Stroop Color-Word Test;Auditory Vocabulary Learning Test;Digit n-back task;Objective Sleep Parameters;Physical activity level;Traditional Chinese Medicine (TCM) Syndrome Efficacy Indicators;Magnetic Resonance Imaging; | — |
Countries
China
Contacts
Public ContactLiu Zhizhen
Fujian University of Traditional Chinese Medicine
Outcome results
None listed