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Clinical efficacy and safety evaluation of Yi Xin Ding Ji Formula in the treatment of paroxysmal atrial fibrillation (Heart yang deficiency pattern)

Clinical efficacy and safety evaluation of Yi Xin Ding Ji Formula in the treatment of paroxysmal atrial fibrillation (Heart yang deficiency pattern)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000284
Enrollment
Unknown
Registered
2025-02-16
Start date
2024-11-01
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

paroxysmal atrial fibrillation

Interventions

control group:Conventional Western Medicine Treatment
treatment group:Conventional Western Medicine Treatment and Yi Xin Ding Ji Formula

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional 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 paroxysmal atrial fibrillation; 2.It meets the diagnostic criteria for traditional Chinese medicine Palpitations Heart yang deficiency pattern; 3.age =18 and =80 years old gender is not limited; 4.atrial fibrillation episodes frequency =2 times/month; 5.The subject has informed consent to participate in this study signed an informed consent form and is able to cooperate with treatment.

Exclusion criteria

Exclusion criteria: 1. Valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, congenital heart disease with atrial fibrillation; 2. Atrial fibrillation triggered by reversible causes such as hyperthyroidism, electrolyte disorders, drugs, etc.; 3. Accompanied by sick sinus node syndrome or serious arrhythmia (high atrioventricular block, ventricular tachycardia, ventricular fibrillation, etc.); 4. Patients with cardiac pacemaking, coronary bypass grafting, and cardiac valves after heart valve surgery in the last 3 months; 5. Severe cardiac insufficiency (NYHA classification > ? or LVEF class III or LVEF < 40%); 6. Accompanied by coagulation disorders or bleeding tendency; 7. Combined systemic infections, malignant tumours, abnormalities of hepatic and renal function; 8. Suffering from severe psychiatric disorders or cognitive dysfunction; 9. Pregnant or lactating women or patients who plan to prepare for pregnancy in the near future; 10. Allergic, allergic to Multiple drug allergies; 11. Those who have received or are receiving traditional Chinese medicine treatment for 2 months; 12. Those who have participated or are participating in clinical trials of other drugs 1 month prior to enrolment.

Design outcomes

Primary

MeasureTime frame
The effective rate of treatment for paroxysmal atrial fibrillation;

Secondary

MeasureTime frame
Ferritin, transferrin;Traditional Chinese Medicine syndrome score and syndrome therapeutic effect;NT-proBNP and Growth stimulation expressed gene 2;homocysteine;EHRA points;blood fat;Recurrence rate of atrial fibrillation;Echocardiogram;24 hours dynamic electrocardiogram;Atrial Fibrillation Effect on Quality-of-Life;URIC ACID;

Countries

China

Contacts

Public ContactShen Yan

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

sheny26@126.com18930568212

Outcome results

None listed

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