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Clinical Studies on the Efficacy and Safety of Xinsuning Capsules in the Treatment of Atrial fibrillation

Clinical Studies on the Efficacy and Safety of Xinsuning Capsules in the Treatment of Atrial fibrillation

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000675
Enrollment
Unknown
Registered
2025-04-07
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

atrial fibrillation

Interventions

Control Group:Xinsuning Capsules Placebo + interventionropafenone Hvdrochloride
Treatment Group:Xinsuning Capsules +roceyentionPropafenone HydrochloridePlacebo

Sponsors

Shandong University of Traditional Chinese Medicine Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: RCT: (1) Meets the Western diagnostic criteria for paroxysmal atrial fibrillation; (2) Meets the traditional Chinese medicine differentiation criteria for phlegm heat disturbing the heart syndrome; (3) The frequency of atrial fibrillation attacks is 22 times per month; (4) Age between 18 and 80 years old gender not limited; (5) The patient provides informed consent and signs the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Merge severe cardiovascular diseases including hypertension grade 3 or above valvular heart disease congenital heart disease acute coronary syndrome requiring revascularization etc; (2) Heart failure with NYHA grade IV or reduced ejection fraction; (3) Patients with poorly controlled hyperthyroidism sleep apnea syndrome diabetes (glycosylated hemoglobin value exceeds 10%) acute exacerbation of chronic obstructive pulmonary disease severe autoimmune disease and malignant tumor; (4) Obese patients (BMI = 28kg/m2); (5) Patients with severe primary diseases of the brain liver kidney and hematopoietic systems as well as psychiatric disorders who have alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels greater than twice the upper limit of normal values and blood creatinine (Scr) levels greater than the upper limit of normal values; (6) Life expectancy<1 year; (7) Individuals with allergic constitution and those who are allergic to drug ingredients in known experimental drugs; (8) Women or partners who are pregnant breastfeeding or have plans to conceive in the near future; (9) Participate in other clinical studies within one month prior to screening; (10) Researchers believe that individuals who are not suitable to participate in this clinical trial

Design outcomes

Primary

MeasureTime frame
oosaden of atrial fibrllation;chesode,er of atrial fibrilation;Atrial Fibrillation Burden;

Secondary

MeasureTime frame
Additional indicators for blood routine and urine routine: Kidney function;Second Use RateReuse Rate;Heart rate heart rate variability maximum P-wave index secondary index type time limit and P-wave dispersion changes;Cicas haee cfie sinoranes;

Countries

China

Contacts

Public ContactYifei Wang

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

15853150460@163.com15853150460

Outcome results

None listed

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