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A prospective randomized controlled study of Yiqi Fumai Recipe for paroxysmal non-valvular atrial fibrillation

A prospective randomized controlled study of Yiqi Fumai Recipe for paroxysmal non-valvular atrial fibrillation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000906
Enrollment
Unknown
Registered
2025-05-07
Start date
2025-05-10
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Paroxysmal non-valvular atrial fibrillation

Interventions

test group:Yiqi Fumai Recipe and Conventional Western Medicine Treatment
control subjects:Herbal granules placebo and conventional western medicine treatment

Sponsors

Dongfang Hospital of Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Fulfillment of western medical diagnostic criteria for paroxysmal nonvalvular atrial fibrillation. (2) The number of atrial fibrillation episodes is =1 per week in the last 2 weeks. (3) Comply with the diagnostic criteria of Chinese medicine of qi deficiency blood stasis and phlegm-heat disturbing the heart. (4) Age =18 years old. (5) Voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Atrial fibrillation treated with catheter ablation or surgical procedures within the last 3 months; (2) Use of traditional Chinese medicine or participation in other clinical trials and allergy to test drugs within the last month; (3) Atrial fibrillation caused by hyperthyroidism electrolyte disorders or drug effects; (4) Atrial fibrillation combined with sick sinus syndrome high degree of atrioventricular or bifascicular block pre-excitation syndrome and other serious arrhythmias with hemodynamic changes; (5) Atrial fibrillation with congenital heart disease hypertrophic cardiomyopathy dilated cardiomyopathy acute coronary syndromes and cardiovascular diseases with hemodynamic changes Arrhythmia with hemodynamic changes in atrial fibrillation; (5) Congenital heart disease hypertrophic cardiomyopathy dilated cardiomyopathy acute coronary syndromes cardiac 3 Version Date: March 19 2025 Version No. 1.1 origin shock acute myocarditis refractory heart failure or left ventricular ejection fraction of = 40% and other serious heart diseases; (6) Combination of severe hepatic insufficiency (Alanine aminotransferase (6) Combined severe hepatic insufficiency (alanine aminotransferase greater than =3ULN); renal insufficiency (blood creatinine =1.5ULN); cerebrovascular disease with severe sequelae acute stage of rheumatic immune disease acute exacerbation of chronic obstructive pulmonary disease hematological primary disease malignant neoplasm diabetes mellitus combined with severe complications uncontrollable thyroid disease moderate-to-severe psychiatric diseases and other diseases that have seriously affected the main symptoms and the quality of life in the past 2 months as judged by the researcher. (7) Pregnant women breastfeeding women or women of childbearing age with childbearing requirements. (8) Life expectancy is less than one year.

Design outcomes

Primary

MeasureTime frame
Atrial fibrillation load;

Secondary

MeasureTime frame
Palpitations Symptom Score in Chinese Medicine;Number of episodes of atrial fibrillation;AFEQT Atrial Fibrillation Quality of Life Score;Maximum duration of atrial fibrillation episodes;

Countries

China

Contacts

Public ContactXiaoyun Cui

Dongfang Hospital of Beijing University of Chinese Medicine

yun6171@126.com010-67689756

Outcome results

None listed

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