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A multicenter Clinical Study on the efficacy and safety of Lingbao Huxin Dan in the treatment of Sick Sinus Syndrome (Qi deficiency and blood stasis syndrome)

A multicenter Clinical Study on the efficacy and safety of Lingbao Huxin Dan in the treatment of Sick Sinus Syndrome (Qi deficiency and blood stasis syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000241
Enrollment
Unknown
Registered
2025-02-12
Start date
2025-02-15
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Sick sinus syndrome

Interventions

Control group:Basic treatment
Test group:Basic treatment and Lingbao Huxin Dan(Take after meals 4 pills 3 times a day)

Sponsors

Fuwai Hospital Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1)Age greater than 18 years old (including endpoint value) gender is not limited; (2)Sinus bradycardia or slow-fast syndrome that meets Western medical diagnostic criteria for sick sinus syndrome; (3)Meet the Chinese medicine diagnostic criteria for qi deficiency and blood stasis syndrome; (4)Understand and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1)Intracranial disease severe hypoxia hypothermia hypothyroidism obstructive jaundice and vasovagal syncope medications acute inferior myocardial infarction atrioventricular block double knots myocarditis ischemic heart disease and other causes of bradyarrhythmias; (2)Sinus node dysfunction caused by carotid sinus hypersensitivity cerebrovascular accident hyperkalemia vagus nerve tone etc. which inhibits sinus node function; (3)Those who have fainted due to severe bradycardia within 1 month; (4)Patients who are taking heart-rate-slowing medications such as ß adrenergic receptor blockers or non-dihydropyridine calcium channel blockers; (5)Those who plan to implant a pacemaker during the study period or have obvious indications for implantable pacemaker (if there are obvious symptoms caused by sinus node dysfunction); (6)Those who have serious heart liver kidney blood system nervous system and other diseases based on past and present medical history; (7)Patients who participated in other clinical trials within

Design outcomes

Primary

MeasureTime frame
Clinical efficacy overall effective rate;

Secondary

MeasureTime frame
24-hour dynamic electrocardiogram sinus rhythm fastest heart rate;Chinese medicine symptom score;24-hour dynamic electrocardiogram sinus rhythm slowest heart rate;Mean heart rate with sinus rhythm on 24 hours dynamic electrocardiogram.;Total duration of ectopic rhythms (including atrial flutter, atrial tachycardia, and atrial fibrillation) on 24-hour dynamic electrocardiogram;Cardiovascular event rate;Proportion of sinus rhythm duration on 24-hour dynamic electrocardiogram;Proportion of pacemaker implantation;

Countries

China

Contacts

Public ContactYao Yan

Fuwai Hospital Chinese Academy of Medical Sciences

ianyao@263.net.cn010-88322674

Outcome results

None listed

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