An evidence-based evaluation study of YuanJiang decoction in the treatment of symptomatic bradycardia

Not Applicable

• Conditions: Symptomatic bradycardia

• Registration Number: ITMCTR2023000027
• Lead Sponsor: Xiyuan Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
treatment efficacy rate;

Secondary Outcome Measures

Name	Time	Method
the MOS 36-Item Short-Form Health Survey;heart rate variability;plasma neurotransmitters;Bmal1 and Clock in peripheral blood mononuclear cells;