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A randomized double-blind placebo-controlled multicenter clinical trial of the efficacy and safety of the Rejuvenation Combination in the treatment of premature ventricular contractions (heart-spleen deficiency syndrome)

A randomized double-blind placebo-controlled multicenter clinical trial of the efficacy and safety of the Rejuvenation Combination in the treatment of premature ventricular contractions (heart-spleen deficiency syndrome)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001333
Enrollment
Unknown
Registered
2025-07-03
Start date
2024-07-23
Completion date
Unknown
Last updated
2025-07-21

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 subjects:Cephalosporin Combination Analog + Metoprolol Tartrate Tablets
intervention group:Quintessence of Spleen Combination + Metoprolol Tartrate Tablets

Sponsors

Guang'anmen Hospital China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age =18 years =75 years and gender; (2) Meet the diagnostic criteria of functional premature ventricular beats in Western medicine and have =720 premature ventricular beats/24 hours on 24-hour ambulatory electrocardiogram; (3) Meet the Chinese medicine diagnostic criteria of heart-spleen deficiency; (4) Compliance with Class II = Lown Class = Class IVa; (5) Symptoms of premature ventricular contractions lasted for more than 1 week; (6) Informed consent and signing the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with comorbid hypertensive disease whose blood pressure control is still unstable after standardized antihypertensive treatment i.e. systolic blood pressure =160 mmHg and/or diastolic blood pressure =100 mmHg; (2) Combined with various structural heart diseases such as coronary heart disease heart failure cardiomyopathy valvular heart disease mitral valve prolapse pacemaker placement etc.; combined with malignant ventricular arrhythmias (e.g. short-paroxysmal ventricular tachycardia tip-twisting ventricular tachycardia ventricular fibrillation etc.) the development of long QT interval syndrome (QT interval =50ms) or severe conduction block (e.g. II III degree) or other supraventricular Arrhythmia; Combined with malignant tumor serious cerebrovascular disease hepatic or renal insufficiency infectious disease hematological or other systemic diseases mental illness; (3) People with premature ventricular contractions caused by drugs electrolyte disorders (hypokalemia hypomagnesemia) anemia hyperthyroidism and other systemic diseases and unknown causes; (4) Those who are allergic to known components of the test drug; (5) Blood creatinine exceeds the upper limit of normal value or either ALT AST exceeds the upper limit of normal value two times; (6) Women who are pregnant or preparing for pregnancy within six months and women who are breastfeeding; (7) Those who are suspected or confirmed to have a history of alcohol addiction or drug abuse; (8) Those who are unable to discontinue antiarrhythmic drugs other than metoprolol tartrate tablets during the participation phase of this clinical trial; (9) Subjects with surgical indications and the subject's desire to undergo surgical treatment; (10) Those who have participated in other clinical trials within 30 days prior to screening; (11) Those who in the opinion of the investigator are not suitable for participation in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Comparison of the number of episodes of premature ventricular contractions before and after 24-hour ambulatory electrocardiography;

Secondary

MeasureTime frame
Quality of life (SF-36) scores;Chinese medicine evidence assessment;Pittsburgh Sleep Quality Index (PSQI) Scores;Changes from baseline in electrocardiogram indicators;

Countries

China

Contacts

Public ContactJun Li

Guang'anmen Hospital China Academy of Traditional Chinese Medicine

gamyylj@163.com13051458913

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 12, 2026