atherosclerotic obliterans
Conditions
Interventions
control group:Beraprost Sodium Tablets
Test group:Restoration of Tongluo Formula Combined with Berberine Sodium Tablets
Sponsors
Shuguang Hospital Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Clinically diagnosed with lower extremity ASO Fontaine stage II; (2) Meeting TCM syndrome differentiation criteria for gangrene; (3) Aged 40-80 years; (4) Patient voluntarily consents to conservative treatment.
Exclusion criteria
Exclusion criteria: 1) Patients with severe primary diseases involving cardiac, cerebral, hepatic, renal, hematopoietic systems or psychiatric disorders; 2) Complicated by acute diabetic complications (e.g., ketoacidosis) or severe chronic diabetic complications; 3) Critical limb ischemia with poor response to conservative therapy, or presenting surgical indications (severe necrosis/infection); 4) Use of antiplatelet/vasodilators (Alprostadil, Beraprost Sodium, Cilostazol) for diabetic atherosclerosis within 1 week pre-enrollment; 5) Pregnancy or lactation; 6) Hypersensitivity to study medications; 7) Participation in other clinical trials within 3 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-Minute Walk Test; | — |
Secondary
| Measure | Time frame |
|---|---|
| D-Dimer;IL-6;VEGF;Posterior tibial artery blood flow;C(CystatinCCysC);Fibrinogen (FIB);IL-18;transcutaneous oxygen tensionTcPO2;C-reactiveproteinCRP;Foot dorsal artery blood flow;ET-1;femoral artery blood flow;IL-1ß;NLRP3;Toe Brachial Index (TBI);Homocysteine;NO;Total score of traditional Chinese medicine syndrome;GSDMD;Ankle Brachial Index (ABI); | — |
Countries
China
Contacts
Public ContactGuobin Liu
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed