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Clinical Study on Fuyuan Tongluo Formula in Preventing and Treating Restenosis after Interventional Therapy for Lower Extremity Arteriosclerosis Obliterans

Clinical Study on Fuyuan Tongluo Formula in Preventing and Treating Restenosis after Interventional Therapy for Lower Extremity Arteriosclerosis Obliterans

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000933
Enrollment
Unknown
Registered
2025-05-08
Start date
2023-02-23
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

Lower extremity arteriosclerosis occlusion disease

Interventions

control group:Aspirin enteric coated tablets+clopidogrel bisulfate tablets
trial group:Aspirin enteric coated tablets+Clopidogrel bisulfate tablets+Rehabilitation Tongluo Formula

Sponsors

liuguobin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Meets LEASO Western diagnostic criteria Fontaine staging belongs to stages II-IV and TASC grading belongs to ABC level; 2)Meets the LEASO traditional Chinese medicine diagnosis of blood stasis syndrome type; 3) After endovascular balloon dilation treatment; 4) Age range: 40-85 years old; 5) Preoperative ankle brachial index(Ankle brachial indexABI)<0.96) Preoperative toe and ankle index (TBI)<0.7; 7) There are obvious clinical manifestationsSymptoms: such as decreased limb skin temperature intermittent claudication resting pain and toe ulcers; 8) Confirmed lesion location through CTA and color Doppler ultrasound examinationIn the femoral popliteal artery the degree of vascular stenosis is greater than 50%; 9) Voluntarily participate and sign informed consent.

Exclusion criteria

Exclusion criteria: 1) CTA examination confirmed the presence of stenosis and occlusion in all three branches of the arteries below the knee Pregnant or lactating women; 3) Existence of cavityContraindications for internal treatment such as coagulation dysfunction and thrombocytopenia; 4) LEASO patients have undergone other endovascular or surgical treatments; 5)Poor compliance failure to take medication on time affecting efficacy; 6) Patients with lower limb arterial thrombosis and lower limb arterial embolism; 7) Severe liver and kidney function malignant tumorsPatients with mental disorders; 8) Lost to follow-up and irregular follow-up.

Design outcomes

Primary

MeasureTime frame
primary patency rates;

Secondary

MeasureTime frame
erythrocyte sedimentation rate;ankle-brachial index;c-reactive protein;leukocyte;clinical efficacy;D-dimer;Fibrinogen;

Countries

China

Contacts

Public Contactliuguobin

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

15800885533@163.com15800885533

Outcome results

None listed

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