Ventricular premature beat
Conditions
Interventions
Group B:Take the placebo of Songling Xuemai Kang Capsules 3 capsules at a time three times a day for a continuous period of 4 weeks. Then take the actual Songling Xuemai Kang Capsules 3 capsules at a
Group A:Take three Songling Xuemaikan capsules at a time three times a day for four consecutive weeks. Then take the placebo of Songling Xuemaikan capsules three at a time three times a day for anothe
Sponsors
West China Hospital of Sichuan university
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Understand and sign the informed consent form approved by the Ethics Committee; (2) Meet the diagnostic criteria for palpitations in traditional Chinese medicine (TCM) and ventricular premature beats (VPBs) in Western medicine; (3) TCM syndrome differentiation belongs to hyperactivity of liver yang type; Main symptoms: 1) Palpitations aggravated by movement; 2) Chest tightness and shortness of breath/chest tightness. Secondary symptoms: 1) Irritability; 2) Fatigue and weakness; 3) Dizziness and blurred vision; 4) Insomnia with frequent dreams; 5) Five-palm heat; 6) Cold sweating with feverish sensation; 7) Red face; 8) Dry mouth; Tongue and pulse: The tongue is red with little or no coating or a thin yellow coating and the pulse is fine and rapid or intermittent. For syndrome diagnosis one main symptom must be present at a moderate level or above and two secondary symptoms are sufficient for diagnosis. (4) Age 18-65 years gender. (5) Ventricular premature beats (PVCs): Clinically symptomatic PVCs ranging from 800-10000 per 24 hours. (6) Lown grading below class IVa. (7) Willing and able to comply with the examinations and observations stipulated in the trial protocol.
Exclusion criteria
Exclusion criteria: 1. Clear indications for electrical cardioversion or non-pharmacological treatment; 2. Severe conditions requiring the use of other antiarrhythmic medications; 3. Presence of poor prognostic risk factors: premature ventricular contractions not originating from the outflow tract short coupling interval premature ventricular contractions wide QRS duration in premature ventricular contractions interpolated premature ventricular contractions multiple morphologies of premature ventricular contractions and increased premature ventricular contractions during exercise; 4. Accompanying malignant ventricular arrhythmias such as sustained polymorphic ventricular tachycardia shock fibrillation or long QT syndrome (QT interval =50ms) or bradyarrhythmias (10%); 10. Severe primary diseases of the liver kidneys hematopoietic system etc. where blood ALT AST >1.5 times the upper limit of normal blood Cr > upper limit of normal; 11. Use of traditional Chinese medicine and patent Chinese medicine for treating ventricular arrhythmias within one week. 12. Use of antihypertensive drugs within one week. 13. Individuals with severe neurological or psychiatric disorders who cannot fully understand and cooperate. 14. History of alcohol or drug abuse; 15. Allergic constitution or allergy to components of this drug; 16. Pregnancy positive urine pregnancy test result at screening planning to become pregnant during the trial period or breastfeeding and women of childbearing potential who do not agree to take appropriate contraceptive measures during the trial period (not in the pre-menarche stage have not undergone sterilization surgery or have not reached menopause); 17. Participation in other drug clinical trials within 3 months prior to the screening period; 18. Other circumstances deemed inappropriate for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the Chinese version of the Arrhythmia-Specific Questionnaire after baseline observation and at 4 and 8 weeks post-medication.;Changes in the number of premature beats on a 24-hour dynamic electrocardiogram at baseline after 4 weeks of medication and after 8 weeks.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the SPIEGEL Sleep Scale after observation baseline and 4 and 8 weeks post-medication.;Changes in heart rate variability (HRV) analysis at baseline 4 weeks after medication and 8 weeks after medication.;Changes in blood pressure after baseline and 4 weeks 8 weeks after medication;Changes in Traditional Chinese Medicine Syndrome Scores at Baseline After 4 Weeks of Medication and After 8 Weeks;Changes in individual scores of traditional Chinese medicine syndromes after the observation baseline 4 weeks and 8 weeks of medication.; | — |
Countries
China
Contacts
Public ContactXiaobo Pu
West China Hospital of Sichuan University
Outcome results
None listed