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A multicenter, randomized, double-blind, placebo-controlled study of Lian-xia-ling-zhu Granules for the prevention of atrial fibrillation recurrence after radiofrequency ablation.

A multicenter, randomized, double-blind, placebo-controlled study of Lian-xia-ling-zhu Granules for the prevention of atrial fibrillation recurrence after radiofrequency ablation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000372
Enrollment
Unknown
Registered
2026-02-13
Start date
2026-04-01
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Atrial fibrillation

Interventions

Experimental Group:Standard Western medical treatment + Lian-xia-ling-zhu Granules
Control Group:Standard Western medical treatment + Lianxia Lingzhu Granules placebo

Sponsors

Beijing Anzhen Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) 18 years = age = 75 years, gender; (2) With a clear history of atrial fibrillation, having received only one radiofrequency ablation, and successfully converted to sinus rhythm within 1 week of treatment; (3) Consistent with the syndrome of internal disturbance by phlegm-heat in traditional Chinese medicine; (4) Not currently considering undergoing another cardiac radiofrequency ablation; (5) Voluntarily participating in this trial and signing the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Structural heart disease, acute coronary syndrome; (2) Severe liver and kidney dysfunction, malignant tumors, hematological diseases, acute infectious diseases, etc.; (3) Expected survival period <12 months; (4) Participation in or enrollment in other clinical studies within the past month prior to enrollment; (5) Severe cognitive impairment or inability to communicate for other reasons; (6) Women who are planning pregnancy, pregnant, or breastfeeding; (7) Allergy to Lianxiaolingzhú granules or related traditional Chinese medicine.

Design outcomes

Primary

MeasureTime frame
Recurrence rate of atrial fibrillation one year after surgery;

Secondary

MeasureTime frame
The frequency and duration of atrial fibrillation episodes.;Atrial Fibrillation Patients' Quality of Life Questionnaire (AFEQT);Adverse cardio-cerebrovascular event incidence rate;Atrial Fibrillation Burden, Proportion of Cardioversion;Echocardiogram (left atrial anteroposterior diameter, left atrial volume index, and left ventricular ejection fraction);Traditional Chinese Medicine Syndrome Scoring Scale;

Countries

China

Contacts

Public ContactCaihua Sang

Beijing Anzhen Hospital, Capital Medical University

sch9613070@sina.com13439080206

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026