ITMCTR2000003290
Not yet recruiting
Phase 1
The effect of inflammatory mechanism on diabetic limb arterial occlusion and the intervention of ruanjiantongmai granule
Shanghai TCM-Integrated Hospita0 sitesTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Shanghai TCM-Integrated Hospita
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.1\. Aged \>\= 40 and \<\= 80 years;
- •1\.2\. The patients belong to the first and second stage of diabetic limb arterial occlusive disease (according to the clinical diagnosis and curative effect standard of diabetic limb arterial occlusive disease formulated by the vascular Committee of Integrated Chinese and Western Medicine);
- •1\.3\. Have a history of type 2 diabetes;
- •1\.4\. ABI index \< 0\.9;
- •1\.5\. The patient must stop other Chinese medicine treatment, and stop fibrinolysis, vasodilator, anticoagulant and other drugs two weeks ago;
- •1\.6 Sign the informed consent.
- •2\. Diagnostic criteria of traditional Chinese medicine: diabetic limb artery occlusion belongs to the category of gangrene and pulse Bi in traditional Chinese medicine. According to the general and local conditions of the patients, and referring to the syndrome differentiation and classification standard of gangrene in the diagnostic efficacy standard of traditional Chinese medicine, our department formulates phlegm dampness syndrome, the main syndrome is puffiness, bleakness, Weihuang, mental malaise, heavy limbs, pain, numbness, light and fat tongue, slippery moss and slippery pulse.
- •3\. Diagnosis standard of Western medicine: refer to the clinical diagnosis and curative effect standard of diabetic limb arterial occlusive disease formulated by the vascular Committee of Integrated Chinese and Western medicine.
Exclusion Criteria
- •1\. Patients with severe heart, liver and kidney dysfunction, hematopathy and tumor;
- •2\. Pregnant or lactating women;
- •3\. Allergic constitution and those who are allergic to known ingredients or control drugs in the drug;
- •4\. People with mental disorders or consciousness disorders;
- •5\. Diabetic foot has collapsed;
- •6\. Acute lower extremity arterial embolism or thrombosis;
- •7\. Those with severe infection or fever;
- •8\. Acute cardiovascular and cerebrovascular accident.
Outcomes
Primary Outcomes
Not specified
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