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A prospective multi-center randomized double-blind placebo trial of Shenlian Fumai Granules in the treatment of paroxysmal nonvalvular atrial fibrillation

A prospective multi-center randomized double-blind placebo trial of Shenlian Fumai Granules in the treatment of paroxysmal nonvalvular atrial fibrillation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000946
Enrollment
Unknown
Registered
2025-05-10
Start date
2025-05-12
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 nonvalvular atrial fibrillation

Interventions

experimental group:Shenlian Fumai granules and conventional Western medicine treatment in accordance with guidelines
Control group:Chinese medicine granule placebo and conventional Western medicine treatment in accordance with guidelines

Sponsors

Dongfang Hospital of Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) It meets the diagnostic criteria of Western medicine for paroxysmal nonvalvular atrial fibrillation. (2) In the past 2 weeks the number of atrial fibrillation episodes per week was =1. (3) During the screening period Holter was monitored for 72h and atrial fibrillation load was =5%. (4) In line with traditional Chinese medicine Qi deficiency blood stasis phlegm-heat disturbance of the heart syndrome diagnostic criteria. (5) Age =18 years old. (6) Voluntary signing of informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients who have received catheter ablation or surgical treatment for atrial fibrillation within the last 3 months; (2) People who have used traditional Chinese medicine preparations or participated in other clinical trials and are allergic to experimental drugs in the past 1 month; (3) Atrial fibrillation caused by hyperthyroidism electrolyte disturbance and drug influence; (4) Complicated with diseased sinus syndrome high atrioventricular block or double bundle branch block preexcitation syndrome And other severe arrhythmias with hemodynamic changes in atrial fibrillation; (5) Congenital heart disease hypertrophic cardiomyopathy dilated cardiomyopathy acute coronary syndrome heart 3 Release date: March 19 2025 Version number 1.1 Severe heart diseases such as source shock acute myocarditis refractory heart failure or left ventricular ejection fraction =40%; (6) Combined with severe hepatic insufficiency (alanine aminotransferase greater than or equal to 3ULN); Renal dysfunction Total (serum creatinine =1.5ULN); Cerebrovascular disease accompanied by serious sequelae acute phase of rheumatic immune disease Chronic obstructive pulmonary disease (COPD) during acute attack primary disease of blood system malignant tumor diabetes complicated with serious complications Disease uncontrolled thyroid diseases moderate and severe mental diseases etc. have been judged by researchers to have a serious impact of nearly 2 Diseases with major symptoms and quality of life during the month; (7) Pregnant women lactating women or women of childbearing age who have fertility requirements. (8) Life expectancy is less than 1 year.

Design outcomes

Primary

MeasureTime frame
Atrial fibrillation load;The frequency of atrial fibrillation attacks;life quality score;Maximum duration of atrial fibrillation;Scoring of Palpitations Symptoms in Traditional Chinese Medicine;

Countries

China

Contacts

Public ContactJie Wan

Dongfang Hospital of Beijing University of Chinese Medicine

yuezhijie1226@sina.com13811268632

Outcome results

None listed

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