A Multicenter Clinical Observation on the Combination of Tongmai Yangxin Wan and Sotalol Hydrochloride Tablets for the Treatment of Ventricular Premature Contractions (VPCs)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2026000920

Enrollment

Unknown

Registered

2026-04-09

Start date

2026-05-01

Completion date

Unknown

Last updated

2026-04-28

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

Conditions

Ventricular Premature Contraction

Interventions

Treatment group:Sotalol Hydrochloride Tablets and Tongmai Yangxin Wan

Control Group:Sotalol Hydrochloride Tablet

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1)Age =18 years and =70 years, with no gender restrictions; 2) Meets the diagnostic criteria for ventricular premature contractions (VPCs) in Western medicine, with a 24-hour ambulatory electrocardiogram showing premature beats =720 times; 3) Meets the diagnostic criteria for qi-yin deficiency syndrome of palpitations in traditional Chinese medicine; 4) No life-threatening ventricular premature contractions, with Lown classification between II-IVa grades; 5) NYHA classification I-III; 6) Signed informed consent, voluntarily participating and signing the informed consent form.

Exclusion criteria

Exclusion criteria: Patients with severe heart disease, or ventricular premature contractions caused by drug-induced, electrolyte disorders, anemia, hyperthyroidism, or unknown etiology; 2) Patients with coexisting sick sinus syndrome, conduction block, atrial fibrillation, ventricular fibrillation, or other severe arrhythmias; 3) Patients who are unable to discontinue other antiarrhythmic medications; 4) Patients with QT interval prolongation >450ms, severe bradycardia, or renal insufficiency who cannot tolerate sotalol; 5) Patients with severe primary diseases of the liver, kidneys, or hematopoietic system requiring treatment; 6) Patients with mental illness, pregnancy or lactation, allergies, or participation in other clinical trials.

Design outcomes

Primary

Measure	Time frame
24-hour Holter monitoring;	—

Secondary

Measure	Time frame
Cardiac Function Indices;TCM Syndrome Score;Quality of Life Rating;Loading rate;Recurrence rate;Dropout rate;	—

Countries

China

Contacts

Public ContactZhao Yingqiang

Tianjin Research Institute of Traditional Chinese Medicine Affiliated Hospital

zhaoyingqiang1000@126.com13920089969

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026