Evaluation of the efficacy of Ruanjian Qingmai granules in the treatment of peripheral arterial disease after revascularizatio

Early Phase 1

Recruiting

• Conditions: peripheral arterial disease

• Registration Number: ITMCTR2023000056
• Lead Sponsor: Shanghai TCM-Integrated Hospital, Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Clinical data before undergoing revascularization meet the diagnostic criteria of PAD in the Guidelines for Diagnosis and Treatment of Lower Extremity Atherosclerotic Occlusive Disease 2016 compiled by the Vascular Surgery Group of the Surgery Branch of the Chinese Medical Association, as well as meet the diagnostic criteria of desmoplasia in the Diagnostic Efficacy Criteria for Chinese Medicine Internal Medicine Disease (ZY/T001.1-94) of the Chinese People's Republic of China Traditional Chinese Medicine Industry Standard; (2) 40 < age = 90 years old, gender is not limited; (3) have undergone lower limb revascularization within the last 6 months; (4) agree to participate in this clinical trial and voluntarily sign the informed consent.

Exclusion Criteria

(1) patients with acute lower extremity ischemia scheduled for lower extremity revascularization and those with a history of major amputation; (2) patients with occlusion of the common femoral or above, femoro-iliac arteries, or occlusion of the arteries above the groin; (3) patients with inflammatory vascular diseases such as atherosclerotic occlusions of the non-lower extremity arteries such as multiple large arteritis, thrombo-occlusive vasculitis, and others; (4) patients who have had a pulmonary embolism in the last 3 months, a myocardial infarction, severe cardiac failure, transient ischemic attack or acute ischemic stroke and other ischemic events in the past 3 months; (5) allergy to RJQM; (6) the presence of severe hepatic or renal insufficiency, malignant tumors, mental anomalies, pregnancy, or preparation for pregnancy prior to randomization, and other patients considered by the investigator as unsuitable for participation in this study; and (7) those who have been involved in a clinical trial of other drugs in the past 6 months.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint event:Major adverse limb event (MALE) or a composite event of all-cause mortality, with a major adverse limb event defined as a supra-ankle amputation (major amputation) or the need for another major intervention (new bypass surgery, graft repair, thrombectomy or thrombolytic therapy, etc.).;

Secondary Outcome Measures

Name	Time	Method
Secondary endpoint events: subankle amputation (minor amputation); reminor intervention (surgical patch vascular repair, balloon dilatation angioplasty, stenting); major adverse cardiovascular event, defined as a composite of myocardial infarction, stroke, or all-cause mortality; occurrence of in-stent restenosis or progression of the degree of stenosis;;