ITMCTR1900002645
Not yet recruiting
Phase 1
An optimized clinical treatment strategy and its mechanisms for Shen-Qi Sequential Therapy in the prevention and treatment of Diabetic Macrovascular Diseases based on the TCM theory of Latent Pathogen
Hospital of Chengdu University of Traditional Chinese Medicine0 sitesTBD
ConditionsDiabetic Lower Extremity Artery Disease
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Diabetic Lower Extremity Artery Disease
- Sponsor
- Hospital of Chengdu University of Traditional Chinese Medicine
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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;
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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