Shensongyangxin capsule treatment of sinus bradycardia with premature ventricular contractions multi-center,Randomized, double-blind, placebo-controlled clinical study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12002504

Enrollment

Unknown

Registered

2012-09-11

Start date

2012-10-11

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinus bradycardia with premature ventricular heartbeat

Interventions

Test group:Effect of Shensong Yangxin capsule, 4 grains/time

Control group:Placebo of Shensong Yangxin capsule, 4 grains/time

Eligibility

Sex/Gender

Male

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. 18~70, sex not limited; 2. 24 hours of dynamic electrocardiogram in diagnosis of sinus bradycardia (average heartbeat sinus heart rate =45 beats/min); 3. 24 hours of dynamic electrocardiogram for diagnosis of frequent premature ventricular contractions (beat number > 1000/24h); 4. signed informed consent (written).

Exclusion criteria

Exclusion criteria: 1. are less than 18 years of age or older than 70; Severe bradycardia; 2. heartbeat 24 hours average heart rate 10000/24h; 4. 2 in grade II-III degree atrioventricular block; 5. sinus arrest more than 3 seconds, or due to heartbeat slow cause amaurosis or syncope; 6. sustained ventricular tachycardia andventricular fibrillation; 7. combined with rapid atrial arrhythmias (atrial tachycardia, atrial fibrillation, atrial flutter) load > 5%; 8. drug, endocrine, metabolic andelectrolyte disorder caused by sinus bradycardia patients heartbeat; 9. the examination confirmed the diagnosis of acute myocardial infarction, unstable angina or in the presence of severe cardiac insufficiency (NYHA grade II or LVEF55mm; Implantable devices (pacemakers); 11. CRT or ICD) treatment; 12. with severe brain, liver, kidney, blood system disease, mental disease andmalignant tumor; 13. serum creatinine, aspartate transaminase, alanine aminotransferase is higher than the normal value of 1.5 times; 14. serious abnormal blood pressure (systolic blood pressure by >160mmHg, 110mmHg); 15. pregnancy or lactation, the drug allergy; 16. within three months to participate in other clinical trials in patients with; 17. researchers think there is any other unsuitable for selected cases.

Design outcomes

Primary

Measure	Time frame
PVCs number;Average heart rate;	—

Countries

China

Contacts

Public ContactCao Kejiang

The First Affiliated Hospital of Nanjing Medical University

jsphkj@163.com+86 13901599830

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026