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Traditional Chinese medicine Shenqi Compound to improve lower extremity atherosclerosis of patients with type 2 diabetes by affecting blood glucose fluctuation: study protocol for a randomized controlled multicenter trial

Clinical study for the treatment of lower extremity atherosclerosis of patients with type 2 diabetes by tonifying Qi and Yin and promoting blood circlulation to regulate glucose fluctuation based on the theory of Homogeny of Pi and Yi

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900025355
Enrollment
Unknown
Registered
2019-11-23
Start date
2019-11-14
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

type 2 diabetes with lower extremity atherosclerosis

Interventions

Sponsors

Teaching Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Those who voluntarily participate in the trial and sign the informed consent form; 2. Aged 35 to 65 years old; 3. In line with the diagnosis of Western medicine type 2 diabetes and TCM syndrome diagnosis and lower extremity atherosclerosis.

Exclusion criteria

Exclusion criteria: 1. Patients with heart and kidney dysfunction, acute coronary syndrome, cerebrovascular accident, hematopoietic disorders and mental illness; 2. Patients with acute metabolic disorders such as diabetic ketoacidosis within the past 1 month; 3. Pregnant women, lactating women; 4. Severe infection in the past 1 month; 5. Patients with allergic constitution; 6. Uncooperative in run-in period; 7. Having a history of alcoholism or drug abuse.

Design outcomes

Primary

MeasureTime frame
arterial color Doppler ultrasound;

Secondary

MeasureTime frame
Standard deviation of mean blood glucose;TCM syndrome score;Islet function index(islet(CP));Insulin resistance index(Homa-IR(CP));Glucagon-like peptide-1;Average blood glucose level;Blood lipid;Area under the C-peptide curve(SCP);Neutrophil lymphocyte ratio;Area under the glucose curve(SG);Maximum blood glucose fluctuation;Interleukin-6;Glycated hemoglobin;C-reactive protein;

Countries

China

Contacts

Public ContactYa Liu

Teaching Hospital of Chengdu University of Traditional Chinese Medicine

liuyaya918@163.com+86 18908185918

Outcome results

None listed

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