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A random, double-blind, placebo parallel controlled, multi-center clinical trial in the treatment of premature ventricular contraction (Qi-Yin deficiency syndrome) with Shiyao Nourishing heart and palpitation Capsule

A random, double-blind, placebo parallel controlled, multi-center clinical trial in the treatment of premature ventricular contraction (Qi-Yin deficiency syndrome) with Shiyao Nourishing heart and palpitation Capsule

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900020720
Enrollment
Unknown
Registered
2019-01-15
Start date
2017-11-20
Completion date
Unknown
Last updated
2019-04-30

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

Conditions

premature ventricular contraction (Qi-Yin deficiency syndrome)

Interventions

Group 1:Yangxin Dingji Jiaonang
Group 2:Yangxin Dingji Jiaonang Simulator

Sponsors

Beijing Chao-Yang Hospital, Capital Medical University
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 old; 3.Diagnosis of Qi-Yin deficiency syndrome in accordance with TCM 'palpitation' syndrome; 4.According to the diagnosis of premature ventricular contraction in western medicine and the following indicators: 3000 beats/24 hours = premature ventricular beats = 20000 beats/24 hours; 5.Left ventricular ejection fraction (=50%); 6.Stop using other anti-arrhythmic drugs except beta-blocker (excluding sotalol) for more than 5 half-lives (over 2 weeks of traditional Chinese medicine) before admission.

Exclusion criteria

Exclusion criteria: 1.Those who need to be treated with other antiarrhythmic drugs or means; 2.Grade III atrioventricular block; 3.Complicated with severe organic heart disease (cardiomyopathy, hereditary disease, acute viral myocarditis, rheumatic heart disease); 4.Hyperthyroidism; 5.Digitalis poisoning and electrolyte disturbance; 6.Those who have suffered from acute myocardial infarction in the past year and have undergone PCI or cardiac bypass surgery; 7.Systolic blood pressure (= 160 or =90 mmHg) and/or diastolic blood pressure (= 110 mmHg); 8.Severe history of liver and kidney diseases, such as cirrhosis, chronic active hepatitis and chronic renal insufficiency; 9.Severe gastrointestinal disease that affects drug absorption, distribution, metabolism, and excretion or has undergone gastrointestinal surgery that affects drug absorption (e.g., gastrostomy or intestinal resection) 10.Patients with acute stroke within 6 months; 11.history of malignant tumors, alcohol or drug abuse; 12.women of childbearing age who breast-feeding, pregnancy, planned pregnancy or did not take reliable contraceptive measures; 13.disabled patients who could not cooperate with clinical trials (blindness, deafness, dumbness,dysgnosia retardation, limb disability); 14.Allergy or allergic asthma to the ingredients, excipients and materials used in the test 15.Those who participated in other clinical trials within 3 months before the trial.

Design outcomes

Primary

MeasureTime frame
Total effective rate of ventricular premature beats at week 8;

Secondary

MeasureTime frame
Total effective rate of ventricular premature beats at week 4;Changes in the number of premature ventricular beats at week 4 and 8;Changes of single symptoms of traditional Chinese medicine in 4 and 8 weeks (disappearance rate);Therapeutic effect of atrial premature beats at week 4 and 8;

Countries

China

Contacts

Public ContactYang Xinchun

Beijing Chao-Yang Hospital, Capital Medical University

yxc6229@sina.com+86 137 0118 6229

Outcome results

None listed

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