The effect of inflammatory mechanism on diabetic limb arterial occlusion and the intervention of ruanjiantongmai granule

Phase 1

• Conditions: Diabetic limb arterial occlusion

• Registration Number: ITMCTR2000003290
• Lead Sponsor: Shanghai TCM-Integrated Hospita

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Ankle brachial index;Brachial artery blood flow relaxing endothelial function;