Insomnia with ventricular premature beats (Lown grade II-IVa)
Conditions
Interventions
experimental group:Basic medication + Renshen Guipi Pills
control group:Metoprolol succinate sustained-release Tablets + Dexzopiclone Tablets
Sponsors
The Second Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18-65 years old (inclusive of 18 and 65 years old) gender not limited; (2) It meets the Western medical diagnostic criteria for insomnia and the disease course is =3 months; (3) It meets the Western medical diagnostic criteria for ventricular premature beats with a Lown grade of II-IVa; (4) It meets the TCM syndrome differentiation criteria for insomnia with deficiency of both heart and spleen. (5) The total score of the Pittsburgh Sleep Quality Index (PSQI) is > 7 points; (6) Agree to participate in this clinical trial and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Known or suspected to be allergic to the components of the test drug or to beta-blockers dexzopiclone gluten etc. or to have an allergic constitution. (2) Secondary insomnia caused by physical illness or mental disorders: such as narcolepsy environmental sleep disorders circadian rhythm sleep disorders sleepwalking sleep-related breathing disorders obstructive or central sleep apnea syndrome restless legs syndrome etc. (3) Within the past year there has been a history of severe mental illness or emotional disorders (such as severe anxiety disorder depression suicidal tendencies or a history of suicide) or long-term use of central nervous system depressant or stimulant drugs. (4) Contraindications for right zopicron include any of the following diseases: decompensated respiratory insufficiency myasthenia gravis severe sleep apnea syndrome etc. (5) When screening the score of the Hamilton Anxiety Scale is =21 points or the score of the 17-item version of the Hamilton Depression Scale is > 24 points. (6) Within the past month and/or during the trial stage there may have been work and life behaviors such as shift work or crossing three or more time zones. (7) Premature beats (ventricular or atrial) caused by structural heart disease (hypertrophic cardiomyopathy dilated cardiomyopathy ventricular septal defect congenital heart disease etc.) rheumatic heart disease pulmonary heart disease viral myocarditis hyperthyroidism hypokalemia digitalis or quinidine reaction cardiac catheterization or during cardiac surgery in the past or present. (8) ALT and AST= 1.5 times the upper limit of the normal value and SCr > the upper limit of the normal value. (9) Has a history of one of the following serious heart and brain diseases: 1) Experienced unstable angina pectoris or received coronary artery bypass grafting within 3 months or received percutaneous coronary intervention treatment. 2) Myocardial infarction cardiogenic shock or life-threatening arrhythmia has occurred within 6 months. 3) There is a history of left ventricular outflow tract obstruction (such as aortic stenosis idiopathic hypertrophic subvalvular aortic stenosis). 4) Those with pathological sinus node syndrome II or III atrioventricular block or decompensated heart failure (pulmonary edema low perfusion pressure or hypotension) at the time of screening. 5) Acute stroke has occurred within 6 months excluding asymptomatic stroke. (10) Patients with ventricular premature beats who as determined by the researcher have indications for radiofrequency ablation surgery and require surgical treatment. (11) Those with severe peripheral vascular diseases at risk of gangrene. (12) Combined with uncontrolled hypertension (with a history of hypertension at the time of screening currently receiving regular medication treatment and blood pressure measured twice in a consecutive manner =180/110 MMHG at the time of screening). (13) Those who are unable to cooperate or unwilling to cooperate due to concurrent neurological or mental disorders. (14) There are concurrent disabilities as stipulated by law (such as blindness deafness muteness intellectual disability mental disorder etc.). (15) Suspect or confirm a history of alcohol abuse drug abuse or drug abuse. (16) Pregnant women lactating women or those with plans to have a baby in the near future. (17) Participated in other interventional clinical trials within the past three months. (18) Those whom the researcher d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI) score;24-hour ambulatory electrocardiogram ventricular premature beats count; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insomnia Severity Index (ISI) scores;Change from baseline in number of premature ventricular beats on 24-hour ambulatory electrocardiograms;pittsburgh sleep quality index psqi;Insomnia efficacy rate;Brief Health Questionnaire (SF-36) scores;Efficacy of Chinese medicine evidence (healing rate effective rate total effective rate);Athens Insomnia Scale (AIS) scores;Efficacy of 24-hour ambulatory electrocardiography for premature ventricular contractions (overall efficacy rate);Benzodiazepine Withdrawal Symptoms Questionnaire (BWSQ) scores;Lown graded efficacy of premature ventricular contractions; | — |
Countries
China
Contacts
Public ContactZhu Yanmei
The Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed