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The mechanism of the "eliminating symptoms, tonifying qi, and promoting blood circulation" method, which targets protein kinase HIPK2 and inhibits vascular endothelial damage, for the treatment of diabetic peripheral artery disease

The mechanism of the "eliminating symptoms, tonifying qi, and promoting blood circulation" method, which targets protein kinase HIPK2 and inhibits vascular endothelial damage, for the treatment of diabetic peripheral artery disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000676
Enrollment
Unknown
Registered
2026-03-20
Start date
2026-04-06
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Diabetic peripheral artery disease

Interventions

Treatment group:Basic Western medicine treatment combined with Sugar Bi Capsules (4 capsules taken orally, three times a day)
blank group:Western medicine for lowering blood sugar and other basic treatments.

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine - University Town Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for diabetic peripheral vascular lesions; (2) Meets the diagnostic criteria for blood stasis syndrome; (3) Age between 18 and 80 years, gender; (4) Voluntarily participates in this trial and signs the informed consent form; (5) The signing of the informed consent form complies with GCP requirements.

Exclusion criteria

Exclusion criteria: (1) Patients with acute complications such as diabetic ketoacidosis, hyperglycemic hyperosmolar syndrome, diabetic lactic acidosis, or acute gout; (2) Individuals with cancer or failure of major organs such as heart, liver, or kidney; (3) Pregnant or breastfeeding individuals, or those planning pregnancy within the next year; (4) Individuals who have participated in other clinical studies within the past three months; (5) Patients who cannot understand the nature, scope, and potential outcomes of the study, or cannot follow medical instructions; (6) Patients with mental illness.

Design outcomes

Primary

MeasureTime frame
Lower extremity artery ultrasound;

Secondary

MeasureTime frame
Ankle-Brachial Index (ABI);Vascular Endothelial Growth Factor (VEGF);Endothelin-1 (ET-1);Interleukin-6 (IL-6);C-reactive protein (CRP);Nitric Oxide (NO);Blood Metabolomics;Transcriptomics;Proteomics;Epigenomics;lncRNA-GAS5;miR-221-3p;HIPK2;

Countries

China

Contacts

Public ContactWei Song

Guangdong Provincial Traditional Chinese Medicine University Town Branch Hospital (Endocrinology Department)

13926001008@139.com13926001008

Outcome results

None listed

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