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Study for the assessment of efficacy, safety and benefit-risk of Xinsuning capsule on the treatment for premature ventricular beats

Study for the assessment of efficacy, safety and benefit-risk of Xinsuning capsule on the treatment for premature ventricular beats

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024979
Enrollment
Unknown
Registered
2019-08-05
Start date
2019-11-15
Completion date
Unknown
Last updated
2019-11-11

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

Conditions

premature ventricular beats

Interventions

Experimental medicine group:Xinsuning capsule, placebo of metoprolol tartrate
Positive medicine group:Metoprolol tartrate, placebo of Xinsuning capsule
the group of combining traditiaonal Chinese Medicine and western medicine:Xinsuning capsule, Metoprolol tartrate
placebo group:placebo of Xinsuning capsule, placebo of Metoprolol tartrate

Sponsors

Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Signing the informed consent voluntarily; 2. Aged 18 to 75 years; 3. In line with the western medicine diagnosis of premature ventricular contraction and meeting the following indicators: ventricular premature beat >= 3000 times /24 hours; 4. Symptoms of premature ventricular beats lasting for more than 1 week.

Exclusion criteria

Exclusion criteria: 1. Patients who are seriously ill,need to be treated with other antiarrhythmic drugs; 2. Acute coronary syndrome (patients with acute st-segment elevation myocardial infarction, acute non-st-segment elevation myocardial infarction and unstable angina); 3. The patients whose NYHA graded III, IV or left ejection fraction <40%; 4. Premature ventricular beats caused by other systemic diseases (such as anemia, hyperthyroidism, etc.), digitalis poisoning and electrolyte disorders; 5. Pregnant or lactating women, mentally illness; 6. Heart rate <60 beats /min; 7. Patients with severe primary diseases such as liver, kidney and hematopoietic system, in which the upper limit of ALT, AST and Cr 1.5 times more than the normal in the blood; 8. Performed cardiac PCI or bypass surgery in the recent 3 months; 9. Hypertension graded 3 or above, with unstable blood pressure controllment; 10. Patients treated with metoprolol tartrate tablets within 1 week; 11. Those who are allergic to the drug ingredients of the test or have an allergic constitution; 12. Participating in other clinical trials within 3 months prior to the trial.

Design outcomes

Primary

MeasureTime frame
Effect of 24-hour dynamic electrocardiogram;

Secondary

MeasureTime frame
Number of diurnal premature ventricular beat;The efficacy of 24-hour Holter;the score of SAS scale;

Countries

China

Contacts

Public ContactMing Ren

Baokang Hospital of Tianjin University of TCM

renming2008@126.com+86 13102193001

Outcome results

None listed

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