The efficacy and safety of chinese herbal medicine Shen-Qi Hua-Yu formula in patients with diabetic lower extremity artery disease: a multi-centre, randomized, double-blind, placebo-controlled trial
- Conditions
- Diabetic Lower Extremity Artery Disease
- Registration Number
- ITMCTR1900002645
- Lead Sponsor
- Hospital of Chengdu University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
To be included in the study, patients must have:
(1) Diagnosis of LEAD of diabetes as well as Qi-yin deficiency with blood stasis syndrome according to WM and TCM;
(2) According to Fontaine stage of LEAD, patients with stage I, IIa and IIb are eligible;
(3) Aged between 35 and 75 years;
(4) HbA1c <= 9.0%;
(5) Women of childbearing age are required negative pregnancy test and agree to use reliable contraception measures during the study;
(6) Voluntarily participate in the test and sign the informed consent;
Patients will be excluded from the study if they meet any of the following criteria:
(1) Patients with cardiac and renal insufficiency, acute coronary syndrome, cerebrovascular accident, vasculitis, venous dysfunction of lower limbs, hematopoietic system disorders and mental diseases;
(2) Patients with acute metabolic disorders such as diabetic ketoacidosis within the past 1 month;
(3) Severe infection in the past 1 month;
(4) Patients with allergic constitution;
(5) Uncooperative in run-in period;
(6) Having a history of alcoholism or drug abuse;
(7) A history of another clinical study in the previous 3 months;
(8) Patients considered by the investigator to be unfit for this study.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method