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

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

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003290
Enrollment
Unknown
Registered
2020-05-10
Start date
2020-06-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic limb arterial occlusion

Interventions

Sponsors

Shanghai TCM-Integrated Hospita
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Ankle brachial index;Brachial artery blood flow relaxing endothelial function;

Countries

China

Contacts

Public ContactXu Liying

Shanghai TCM-Integrated Hospital, Affiliated to Shanghai University of Chinese Medicine

newlihappy@sina.com+86 13564751124

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026