Diabetic lower extremity arterial occlusive disease
Conditions
Interventions
Treatment group:Daphne Capsules
Control group:Daphne Capsules Placebo
Sponsors
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for diabetic lower extremity arteriosclerosis obliterans; (2) Age 40–65 years; (3) Fontaine stage I–III patients; (4) Those who received other treatments before the trial must have discontinued them for at least 2 weeks; (5) No speech or intellectual impairments and able to smoothly answer and complete questionnaires; (6) All participants voluntarily participate in the study and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Does not meet the inclusion criteria; (2) Patients diagnosed with acute lower limb ischemia, acute complications of diabetes, severe cardiovascular diseases, sexually transmitted diseases, malignant tumors, peptic ulcers, or bleeding disorders that may affect the study results; (3) Patients with liver or kidney dysfunction, or with aspartate aminotransferase (ALT) or alanine aminotransferase (AST) levels exceeding 1.5 times the upper limit of normal, or creatinine levels exceeding the upper limit of normal and considered clinically significant; (4) Patients allergic to Ruixiangsu capsules or certain components thereof, or those who meet the contraindications of Ruixiangsu capsules; (5) Patients who participate involuntarily or cannot cooperate to complete the study; (6) Patients who have participated in other clinical trials within the past 3 months; (7) Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ankle-brachial index;Painless walking distance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood flow and blood flow velocity of lower limb arteries and dorsalis pedis arteries;Markers of inflammation;Vascular endothelial function;Lipid profile;Clinical signs and symptoms; | — |
Countries
China
Contacts
Public ContactNi Qing
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed