Bradycardia
Conditions
Interventions
Observation group:Xinbao Pill administration method follows package insert recommendations, but actual regimen determined by investigators based on patient tolerance (dose may be adjusted if well tole
Sponsors
Beijing University of Chinese Medicine Dongzhimen Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Meet Western diagnostic criteria for bradycardia, with average 24-hour Holter heart rate <60 bpm at enrollment; (2) Meet TCM diagnostic criteria for heart-kidney Yang deficiency and/or heart vessel blood stasis; (3) Age 18-85 years, any gender; (4) Voluntary informed consent signed.
Exclusion criteria
Exclusion criteria: Exclusion criteria (all must be excluded for enrollment): (1) History of recurrent syncope, Adams-Stokes attacks, or glaucoma; (2) Severe cardiac, hepatic, renal, hematological, neurological, or endocrine diseases (e.g., NYHA class >III, ALT/AST >2×ULN, Scr >1.5×ULN), or other life-threatening conditions; (3) Participation in other interventional studies within 1 month prior to screening; (4) Pregnant/lactating women or psychiatric patients; (5) Allergy to Xinbao Pill components or allergic constitution; (6) Investigator's judgment of unsuitability for trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall efficacy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in 24-hour Holter parameters (average HR, minimum HR, maximum HR, duration of ectopic rhythms [atrial flutter/tachycardia/fibrillation], conduction block severity, sinus pauses);The change in Traditional Chinese Medicine (TCM) symptom scores from baseline.;Changes from baseline in SF-12 quality of life scores;Proportion of newly implanted pacemaker patients;Pacemaker programming parameters, device longevity, pacing percentage;Incidence of major cardiovascular events; | — |
Countries
China
Contacts
Public Contactwangxian
Beijing University of Chinese Medicine Dongzhimen Hospital
Outcome results
None listed