Clinical Study of Tongmai Yangxin Pill in Treating Slow Arrhythmia (Qi-Yin Deficiency Syndrome)

Phase 4

• Conditions: Slow arrhythmia

• Registration Number: ITMCTR1900002578
• Lead Sponsor: The Second Affiliated Hospital of Tianjin University 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. It meets the diagnostic criteria of TCM palpitations of qi Yin deficiency syndrome and western medicine sinus bradycardia, atrioventricular block and pathological sinus atrial node syndrome.
(1) sinus bradycardia: 24-hour dynamic ecg average heart rate < 60 times/min, 24h total heart rate < 86400 times;
(2) sick sinus syndrome;
(3) atrioventricular block;
(4) occasional sinus arrestThose who do not meet the pacemaker standard or refuse to install pacemaker and have no history of fainting and amaurosia.
2. Aged from 35 to 75 years, regardless of gender.
3. Voluntarily participate in this study and sign the informed consent.

Exclusion Criteria

1. Patients with severe primary diseases of cerebrovascular, liver, kidney and hematopoietic system and severe cardiopulmonary insufficiency; Severe anemia, hypothyroidism, electrolyte disorder and drug - induced chronic arrhythmia patients.
2. Congenital heart disease, severe angina pectoris, acute stage of myocardial infarction, acute stage of middle or severe viral myocarditis and hypertensive crisis.
3. Sinus bradycardia with short paroxysmal atrial fibrillation, atrial flutter, supraventricular tachycardia.
4. Women who are pregnant, preparing for pregnancy or lactation and who are allergic to this drug.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Dynamic electrocardiogram;Electrocardiogram;Clinical symptoms and changes of tongue and pulse;