Paroxysmal atrial fibrillation
Conditions
Interventions
Test group:Qipo Shengmai Granules:10g
bid.
Control group:Qi Po Sheng Mai Granule Simulator:10g bid.
Sponsors
Guang'anmen Hospital,China Academy of Traditional Chinese Medicine.
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for paroxysmal atrial fibrillation/atrial flutter; (AF/AFL burden = 0.5% and = 70% can be detected by 7-day Holter monitor); (2) Conforming to the TCM syndrome differentiation standards for both Qi and Yin deficiency; (3) Age 18-75 years old, both male and female; (4) Volunteer to receive medication treatment and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Valvular atrial fibrillation (such as Mitral stenosis or severe mitral insufficiency); The inner diameter of the left atrium is greater than 50mm. (2) Atrial fibrillation caused by other reasons (such as hyperthyroidism or hypothyroidism, Pericarditis, Myocarditis or pulmonary embolism); (3) Severe cardiac insufficiency (NYHA ?, V) or left ventricular Ejection fraction (LVEF)450ms, female>470ms; Family history of long QT syndrome or congenital long QT syndrome; (5) Percutaneous coronary intervention, percutaneous coronary angioplasty or Coronary stent, myocardial infarction or other heart surgery during the 3-month period; (6) Use other Class I and III antiarrhythmic drugs without slow withdrawal for more than 5 half lives; Use Amiodarone within 3 months before screening. (7) Severe or uncontrolled hypertension (= 180/110mmHg) or Hypotension (SBP = 80mmHg); (8) Allergic constitution, or Food allergy to multiple drugs, or patients known to be allergic to excipients of drugs; (9) Patients with abnormal liver and kidney function indicators (ALT, TBIL greater than 1.5 times the upper limit of normal value, Scr greater than the upper limit of normal value); (10) Pregnant or lactating women, or those who have a pregnancy plan in the past 3 months; (11) Patients who have participated in other clinical trials within the past month; (12) Suspected or with a history of alcohol or drug abuse; (13) Patients with mental illness; (14) Researchers believe that there are patients with unsuitable factors for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AF/AFL burden;Evaluation of atrial fibrillation symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total duration of AF/AFL episodes;Duration of the longest AF/AFL attack;Number of AF/AFL episodes;Percentage of patients with reduced AF/AFL burden from baseline by = 30% or = 50%;Heart rate variability;p wave dispersion;EHRA atrial fibrillation symptom score;Improvement of Traditional Chinese Medicine Syndrome Points;quality of life; | — |
Countries
CHINA
Contacts
Public ContactYuanhui Hu
Guang'anmen Hospital,China Academy of Traditional Chinese Medicine.
Outcome results
None listed