A randomized controlled trial of Ruanjian Qingmai Granule in the treatment of peripheral arterial disease

Phase 1

• Conditions: peripheral arterial disease

• Registration Number: ITMCTR2200005580
• Lead Sponsor: shanghai TCM-Integrated Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

Inclusion Criteria

(1) Meet diagnostic criteria of PAD: ? Age > 40 years old, with smoking, diabetes, hypertension, hyperlipidemia and other high-risk factors, there are clinical manifestations of lower limb ischemia, such as intermittent claudication, affected limb skin temperature drop, numbness, skin hair loss and other affected limb dorsal or posterior tibial artery pulse weakened or disappeared; ?ABI 0.9 or less; ? Color Doppler ultrasound, CTA, MRA or DSA imaging examination showed stenosis or occlusion of the corresponding lower limb arteries;
(2) Meet the diagnostic criteria of TCM (syndrome of phlegm-dampness blocking collaterals):
Phlegm and dampness syndrome: sore and swollen, fatigued, swollen;
Blood stasis syndrome: main syndrome: ? lower limb pain, dark red skin color or low skin temperature; ? Intermittent claudication; ? The pulsatile of dorsalis pedalis and posterior tibial artery was weakened or disappeared;
Secondary syndromes: The skin is dry and desquamate, the limbs are cool and numb, the toenails are thickened, the hair is sparse, and the limbs are throbbing and muscle twitching.
Tongue image: dark red with petechiae;
Pulse: heavy and astringent pulse.
(3) Patients with PAD (Fontaine ? or Rutherford ?) showed intermittent claudication with no significant exacerbation in the recent one month;
(4) 40 < age =80, no gender limitation;
(5) The patients agreed to participate in the clinical trial and voluntarily signed the informed consent.

Exclusion Criteria

? There are other diseases that affect the walking distance, such as lower limb ulcer, gangrene, arthropathy, spinal disease, lower limb venous disease, etc.
? Patients with acute or severe extremity ischemia, planned lower extremity vascular reconstruction, and a history of amputation;
? Patients were diagnosed with unstable angina pectoris, myocardial infarction, heart failure (?, ?) and transient cerebral ischemia within the last 3 months;
? Patients with poor blood glucose control (HbA1c>10.0%) and poor blood pressure control (systolic blood pressure =160mmHg or diastolic blood pressure =100mmHg);
? patients with femoral artery occlusion, femoral iliac artery occlusion and inguinal artery occlusion;
? Patients with inflammatory vascular disease, such as multiple arteritis, peripheral vascular edema, thromboangiitis obliterans and other non-lower limb atherosclerosis obliterans diseases;
? Patients with liver and kidney dysfunction, malignant tumors, mental abnormalities and other patients considered by researchers to be unsuitable to participate in this study;
? Patients who have been allergic to any drugs or excipients in the study, or have been allergic to other similar products;
? The patients who have participated in clinical trials of other drugs within the last 6 months.

Study & Design

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