Clinical effect of Xinhuankangkeli on bradyarrhythmias

Not Applicable

• Conditions: Bradyarrhythmias

• Registration Number: ITMCTR2200005738
• Lead Sponsor: Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

(1) Age 18~80 years old
(2) Meet the diagnostic criteria of Western medicine for bradyarrhythmia (50 beats/min=HR<60 beats/min; 60000 beats=24 hours Holter heart rate =85000 beats)
(3) Meet the diagnostic criteria of TCM heart-yang deficiency syndrome
(4) No use of atropine, isoproterenol or related drugs or traditional Chinese medicine treatment methods such as Chinese medicine decoction, acupuncture and moxibustion within 1 month to increase heart rate.
(5) Voluntarily participate in the trial and sign the informed consent form

Exclusion Criteria

(1) There is a long interval of R-R>3 seconds in the 24-hour Holter
(2) Rapid and slow syndrome, Aspen syndrome, severe sinoatrial node block (HR=35 times/min), second-degree type II atrioventricular block, third-degree atrioventricular block, bradycardia With paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia
(3) Stress state: such as vagus nerve stimulation test
(4) Electrolyte disturbance, anemia, intracranial disease, obstructive jaundice, hypothyroidism, hyperkalemia and application of cholinergic drugs, congenital cardiovascular disease, unstable angina, acute myocardial infarction, virus bradyarrhythmias caused by myocarditis, essential hypertension, etc.
(5) Serum potassium >5.5mmol/L or <3.5mmol/L
(6) Those who have been allergic to the drug ingredients in the past
(7) Pregnant and lactating women
(8) Patients with severe hepatic and renal insufficiency
(9) Failure to take medicines as required, taking other medicines during the clinical observation period affects the efficacy evaluation of the drug in this trial, and currently participating in clinical trials of other medicines or external therapy

Study & Design

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

Primary Outcome Measures

Name	Time	Method
24-hour Holter monitor;

Secondary Outcome Measures

Name	Time	Method
Heart rate variability;Blood pressure;