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A multicenter prospective randomized double-blind placebo-controlled study on the efficacy and safety of Qidong Yixin granules in the treatment of premature ventricular contractions

A multicenter prospective randomized double-blind placebo-controlled study on the efficacy and safety of Qidong Yixin granules in the treatment of premature ventricular contractions

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000690
Enrollment
Unknown
Registered
2025-04-10
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

premature ventricular contraction

Interventions

control group:Placebo granules: oral 5g/bag TID
test group:Astragali Dong Yi Xin Granules: Oral 5g/bag TID

Sponsors

Zhongshan Hospital Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the criteria for premature ventricular contractions: symptomatic complaints of palpitations or chest tightness ECG meets the diagnostic criteria for premature ventricular contractions and the number of episodes of premature ventricular contractions is between 2000-20000 episodes/24h on 24h ambulatory electrocardiogram; 2. Age 18-75 years old gender is not limited; 3. Voluntarily undergo the test and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. patients with combined organic heart disease (e.g. coronary heart disease cardiomyopathy congenital heart disease valvular disease heart failure etc.); 2. Subjects who are unable to understand and complete the relevant scale due to language vision intellectual disabilities etc; 3. Those who need to be treated with other anti-arrhythmic drugs for serious conditions in the past month; 4. Subjects who have used traditional Chinese medicines or proprietary Chinese medicines with similar efficacy to the test drug in the past month; 5. Arrhythmia caused by drugs electrolyte or acid-base balance disorders; 6. Combined bradyarrhythmia (including sick sinus syndrome and atrioventricular block of degree II or above) sinus heart rate less than 50 beats/minute those who need to install a pacemaker or those who already have a pacemaker or those who have severe sinus node dysfunction; 7. Combined persistent atrial fibrillation ventricular fibrillation torsional ventricular tachycardia sustained ventricular tachycardia or non-sustained ventricular tachycardia accompanied by rapid ventricular rate and hemodynamic disorders; 8. those who have a reduction in premature beats after removal of triggers (e.g. exertion stress mood swings alcohol abuse etc.) along with significant relief of symptoms; 9. patients with severe hypotension and poor blood pressure control (systolic blood pressure = 140 mm Hg diastolic blood pressure = 90 mm Hg); 10. Combined serious heart (congestive heart failure cardiogenic shock etc.) cerebrovascular disease combined liver kidney and hematopoietic system and other serious primary diseases (ALT AST is higher than the upper limit of the normal value of two times or Cr is higher than the upper limit of the normal value); 11. Allergy to known components of the test drug and allergy; 12. Pregnant and breastfeeding women who are preparing for pregnancy in the near future; 13. Long-term alcoholics drug-dependent persons patients with mental illnesses 14. People with serious respiratory digestive hematologic infectious immunological endocrine neuropsychiatric oncological diseases or diseases that may cause serious danger to the patients; 15. patients who are participating in other clinical studies; 16. those who are considered by the investigator to be unsuitable for participation in the clinical trial.

Design outcomes

Primary

MeasureTime frame
Overall effectiveness in treating premature ventricular contractions;

Secondary

MeasureTime frame
Change from baseline in number of premature beats;Change from baseline in clinical symptom score;Change from baseline in the Quality of Life Survey Scale (SF-36);

Countries

China

Contacts

Public ContactJunbo Ge

Zhongshan Hospital Fudan University

ge.junbo@zs-hospital.sh.cn+86 021-64041990

Outcome results

None listed

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