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Clinical evaluation of Yifei Tiaoxue Formula in the treatment of acute pulmonary thromboembolism with high risk of bleeding

Clinical evaluation of Yifei Tiaoxue Formula in the treatment of acute pulmonary thromboembolism with high risk of bleeding

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001196
Enrollment
Unknown
Registered
2025-06-16
Start date
2024-10-18
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Acute pulmonary thromboembolism

Interventions

Western Medicine Group:Anticoagulation therapy
Integrated Traditional Chinese and Western Medicine Group:Yifei Tiaoxue Formula Instant Granules combined with anticoagulation therapy

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Age =18 years; (2) Diagnosed with acute pulmonary thromboembolism (PTE) with or without deep vein thrombosis (DVT); (3) Non-high-risk stratification of PTE; (4) According to the Guidelines for the Diagnosis Treatment and Prevention of Pulmonary Thromboembolism presence of at least one of the following high-risk bleeding factors: age >75 years; history of stroke within the past 3 months; history of surgery within the past 3 months; malignancy; thrombocytopenia; diabetes mellitus; anemia; or current antiplatelet therapy; (5) Syndrome of qi deficiency and blood stasis (traditional Chinese medicine diagnosis); (6) Cumulative use of anticoagulants or Qi-invigorating and blood-activating herbal formulas for no more than 3 days within the 30 days prior to baseline; (7) Voluntary participation in the study with signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients requiring anticoagulation with warfarin; (2) Concomitant liver or kidney dysfunction (any one of ALT AST Scr or BUN exceeding the upper limit of normal reference values); (3) Severe diseases of the digestive nervous hematologic or cardiocerebrovascular systems or severe mental disorders; (4) Having undergone thrombolytic therapy interventional procedures or surgical treatment.

Design outcomes

Primary

MeasureTime frame
Residual Thrombus;Bleeding Event;

Secondary

MeasureTime frame
VTE Recurrence;All-Cause Mortality;VTE-Related Mortality;Quality of Life Score (PEmb-QoL);

Countries

China

Contacts

Public ContactDemin Li

China-Japan Friendship Hospital

demin2008@sina.com13811830348

Outcome results

None listed

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