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Multi-center evidence-based clinical evaluation of Lingbao Huxin Dan in the treatment of paroxysmal atrial fibrillation

Multi-center evidence-based clinical evaluation of Lingbao Huxin Dan in the treatment of paroxysmal atrial fibrillation

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001107
Enrollment
Unknown
Registered
2025-06-03
Start date
2025-03-05
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Paroxysmal atrial fibrillation

Interventions

Control Group:Standard Western medical treatment
Experimental Group:Standard Western medical treatment + Lingbao Huxin Dan (Lingbao Huxin Dan taken after meals 3 times a day 4 pills per dose)

Sponsors

Longhua Hospital Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria (1) Age between 18 and 85 years regardless of gender. (2) Meets the diagnostic criteria for paroxysmal atrial fibrillation with a frequency of =2 episodes per month or persistent atrial fibrillation (at least one diagnosis confirmed by ECG). (3) Has a correct understanding of the significance of the study demonstrates good compliance with the investigators observations and evaluations and voluntarily agrees to participate in the clinical trial by signing the informed consent form. the investigators observations and evaluations and voluntarily agrees to participate in the clinical trial by signing the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion Criteria (1) Patients with severe pulmonary hepatic or renal insufficiency primary hematologic diseases or severe cardiac dysfunction (NYHA class IV). (2) Patients with psychiatric disorders that are poorly controlled. (3) Patients with a heart rate below 50 beats per minute (e.g. those planning to receive a pacemaker). (4) Pregnant or lactating women. (5) Patients in the cachectic state of terminal malignant tumors. (6) Patients with known allergies to the study drug components. (7) Patients with poor compliance or those deemed unsuitable for the study by the investigator.

Design outcomes

Primary

MeasureTime frame
Dynamic electrocardiogram index;EHRA atrial fibrillation symptom score;

Secondary

MeasureTime frame
Hamilton Depression Scale assessment;The cumulative number and duration of palpitations;Summary of the SF-36 Health Survey;proBNP;Cardiac ultrasound;Hamilton Anxiety Scale assessment;

Countries

China

Contacts

Public ContactDeng Bing

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Dengbing82@sina.com64385700-3625

Outcome results

None listed

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