Symptomatic bradycardia
Conditions
Interventions
Treatment group:YuanJiang decoction
Control group:placebo
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria for SND or AVB; 2. Patients presenting with corresponding clinical symptoms such as dizziness, blurred vision, fatigue, palpitations, chest tightness, etc., and where the onset of symptoms is clearly related to bradycardia; 3. Individuals who meet the indications for pacemaker implantation but have declined pacemaker treatment; 4. Patients who conform to the criteria for Yang-deficiency and blood stasis syndrome in TCM; 5. Age between 18 and 80 years old; 6. Willingness to participate in the study and provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Individuals with a maximum RR interval greater than 5 seconds or a minimum heart rate of 35 beats on a 24-hour ambulatory electrocardiogram; 2. Patients with third-degree or high-degree atrioventricular block; 3. Previous history of syncope due to bradycardia; 4. Patients with severe cardiac, pulmonary, cerebral, or hematologic disorders, including but not limited to those conditions such as acute myocardial infarction within the last 2 weeks, unstable angina, ventricular tachycardia, ventricular fibrillation, and poorly controlled hypertension; 5. Transient secondary bradyarrhythmia caused by medications; 6. Athletes with low heart rate but normal sinus node function or athletes without arrhythmia-related symptoms 7. Bradycardia caused by hypothyroidism; 8. Pregnant or lactating women 9. Patients with mental illness and substance abuse; 10. Coagulation disorders; 11. Allergic predisposition or known allergy to any of the 6 herbs used in the TJT; 12. Participation in other clinical trials within the last month; 13.Other condition that unable to meet the requirements of the study as judged by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| treatment efficacy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| the MOS 36-Item Short-Form Health Survey;heart rate variability;plasma neurotransmitters;Bmal1 and Clock in peripheral blood mononuclear cells; | — |
Countries
China
Contacts
Public ContactZhang Wantong
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed