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Clinical effect of Xinhuankangkeli on bradyarrhythmias

Clinical effect of Xinhuankangkeli on bradyarrhythmias

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005738
Enrollment
Unknown
Registered
2022-03-17
Start date
2022-03-04
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

Bradyarrhythmias

Interventions

Control group:Placebo
Intervention group:Xinhuankangkeli

Sponsors

Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
24-hour Holter monitor;

Secondary

MeasureTime frame
Heart rate variability;Blood pressure;

Countries

China

Contacts

Public ContactYanwei Xing

Guang'anmen Hospital of Chinese Academy of traditional Chinese medicine

xingyanwei12345@163.com18514733206

Outcome results

None listed

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