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Randomized controlled clinical study on the treatment of atrial fibrillation with Shenlong Tongluo Dingji Formula

Randomized controlled clinical study on the treatment of atrial fibrillation with Shenlong Tongluo Dingji Formula

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000718
Enrollment
Unknown
Registered
2026-03-24
Start date
2026-03-26
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Paroxysmal Atrial Fibrillation

Interventions

Experimental Group (TCM formula + standard therapy):QLTLDJF (200mL, bid) + guideline-based Western treatment (anticoagulation, rate/rhythm control)
Control Group (Standard therapy):Guideline-based Western treatment only (anticoagulation, rate/rhythm control), without Chinese herbal preparations

Sponsors

Beijing University of Traditional Chinese Medicine Dongzhimen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: (1) Age 18-80; (2) Diagnosis of paroxysmal AF with Qi-Yin deficiency and phlegm-stasis syndrome; (3) EHRA class 2-3; (4) Signed informed consent.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: (1) Valvular AF; (2) Hyperthyroidism-induced AF; (3) Planned/prior pacemaker implantation or bradyarrhythmia; (4) NYHA class IV or LVEF=40%; Left atrial diameter>50mm; Moderate-severe LVH (>15mm); (5) Acute coronary syndrome, recent stroke (<3mo), bleeding disorders, left atrial thrombus, severe hepatic/renal dysfunction (ALT=3×ULN or eGFR<50ml/min/1.73m²); (6) Hypersensitivity to study drugs; (7) Pregnancy/lactation.

Design outcomes

Primary

MeasureTime frame
Atrial fibrillation burden;

Secondary

MeasureTime frame
syndrome in traditional Chinese medicine;European Heart Rhythm Association Symptom Scale for Atrial Fibrillation;Peripheral Blood Secreted Phosphoprotein 1;Interleukin-6;Tumor Necrosis Factor-a;Interleukin-1ß;Monocyte Chemoattractant Protein-1;Atrial Fibrillation Effect on QualiTy-of-life Questionnaire;

Countries

China

Contacts

Public ContactWang Xian

Beijing University of Chinese Medicine Dongzhimen Hospital

wx650515@163.com010-84013181

Outcome results

None listed

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