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A multicenter, randomized, double-blind, positive drug parallel-controlled clinical trial of Yangxindingji capsule for the treatment of premature ventricular contractions (with or without bradyarrhythmia)

A multicenter, randomized, double-blind, positive drug parallel-controlled clinical trial of Yangxindingji capsule for the treatment of premature ventricular contractions (with or without bradyarrhythmia)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087963
Enrollment
Unknown
Registered
2024-08-08
Start date
2024-08-16
Completion date
Unknown
Last updated
2024-08-12

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

Conditions

Premature ventricular contractions(with or without bradyarrhythmia)

Interventions

Test group:Yangxindingji capsules+Shengmai Yin (Codonopsis pilosula, low sugar) simulator
Control group:Yangxindingji capsules simulator+Shengmai Yin (Codonopsis pilosula, low sugar)

Sponsors

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.It was in accordance with the diagnostic standard of ventricular premature beats in western medicine; 2.It accords with the standard of TCM syndrome differentiation of palpitation and deficiency of qi and blood; 3. Ventricular premature load (number of premature beats/Total Heart Beats)5% -25%; 4. Age 18-80 years old; 5. Before entering the study group, the patients stopped using Chinese herbs related to ventricular extrasystole for more than 2 weeks, and stopped using other antiarrhythmic agent except ß-blockers (excluding sotalol Lor) for more than 5 half-lives; 6. Sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: 1. Patients with severe organic heart disease (acute myocardial infarction, acute viral myocarditis, cardiomyopathy, rheumatic heart disease), other system diseases (such as anemia, hyperthyroidism, etc.) , digitalis poisoning, electrolyte disorder; Patients who had acute myocardial infarction, underwent PCI or heart bypass surgery, or had acute stroke in the last six months; 2.The heart function was classified as NYHA Class IV; 3.After treatment, the hypertension could not be controlled stably below 150/95 mmhg; 4.Patients with severe primary diseases,such as liver, kidney and hematopoietic system, cancer,were found to have serum ALT and AST > 1.5 times the upper limit of normal, and serum CR > the upper limit of normal; 5.A severe gastrointestinal disease that affects the absorption, distribution, metabolism, and excretion of drugs or has undergone gastrointestinal surgery that affects the absorption of drugs; 6.A history of alcohol, or drug abuse; 7.Pregnant or lactating women, psychiatric patients; 8.The drug ingredients, excipients, capsules allergic; 9.Participants in other clinical trials within 3 months before the trial; 10.The investigators considered that there were patients who were unsuitable for inclusion or who had factors that affected participation or completion of the study.

Design outcomes

Primary

MeasureTime frame
24-hour Holter Monitor;

Secondary

MeasureTime frame
24-hour Holter mean heart rate change value;TCM symptom efficacy points;Change from baseline in the time domain value of heart rate variability;Change in Pittsburgh Sleep Quality Index questionnaire score;Anxiety self-rating scale score;Depression self-rating scale score;

Countries

China

Contacts

Public Contactmingjun,Zhu

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

zhumingjun317@163.com+86 139 0384 6672

Outcome results

None listed

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