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

Phase 1

Not yet recruiting

• 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

Study Timeline

• Last Update Posted: 2023-02-20

Recruitment & Eligibility

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

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.

Study & Design

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