A Non-inferiority Randomized Controlled Trial Comparing the Rehabilitation Effects of Zhenzhongdan and Eszopiclone in Elderly Patients with Insomnia Disorder of the Heart–Kidney Disharmony Pattern

Authors
Category Primary study
Registry of TrialsInternational Traditional Medicine Clinical Trial Registry
Year 2026
INTERVENTION: 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.; CONDITION: 7A0Z Insomnia Disorder PRIMARY OUTCOME: Pittsburgh Sleep Quality Index; SECONDARY OUTCOME: 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; 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 Inde X(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.
Epistemonikos ID: e748831451d490cb4b9cf558d6f5a47641c4174d
First added on: Jul 25, 2026