Efficacy, safety and therapeutic mechanism of Shen-Qi Xiao-Tan Formula in the treatment of peripheral atherosclerosis in patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled trial

Phase 1

Recruiting

• Conditions: diabetic peripheral atherosclerosis

• Registration Number: ITMCTR2100004933
• Lead Sponsor: Hospital of Chengdu University of Traditional Chinese Medicine

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: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. According to Cardiovascular Disease and Risk Management in the Standards of Medical Care in Diabetes (2021 edition) published by American Diabetes Association (ADA), Guideline for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (2020 edition) by Chinese Diabetes Society (CDS), and Guideline for Ultrasound Examination of Blood Vessels and Superficial Organs by Ultrasound Society of Chinese Medical Doctor Association, patients with
(1) Definite diagnosis of T2DM;
(2) Color doppler ultrasound of the carotid or lower extremity arteries suggested intima-media thickening (IMT >= 1mm) and/or atherosclerotic plaque (limited IMT >= 1.5mm).
2. According to Guiding Principles for New Drug Clinical Research of TCM and Guidelines for Prevention and Treatment of Diabetes in TCM by China Association of Chinese Medicine;
3. Aged 30 to 65 years;
4. Patients participate voluntarily and sign the Informed Consent Form;
5. When patients are screened, woman of childbearing age must have a negative urine pregnancy test and agree to use reliable contraception during this trial.

Exclusion Criteria

1. Patients with calcified plaques or unstable plaques in lower extremity or carotid arteries, or arterial stenosis (vascular inner diameter stenosis >= 50%), or arterial occlusion;
2. Patients who have been diagnosed with coronary heart disease by coronary angiography, or whose electrocardiogram (ECG) and clinical manifestations suggest coronary heart disease, or who have had clear cardiovascular and cerebrovascular events, such as acute coronary syndrome and cerebral infarction;
3. Ankle-brachial index (ABI) <= 0.9;
4. Fasting triglyceride (TG) > 5.7 mmol/L;
5. Patients with abnormal liver and kidney function, such as the ratio of serum alanine aminotransferase (ALT) to aspartate aminotransferase (AST) higher than 1.5 times of the upper limit of normal value, creatinine (Cr) higher than the upper limit of normal value, estimated GFR (eGFR) <= 60 ml·min-1·(1.73m2)-1;
6. Patients with acute metabolic disorders such as diabetic ketoacidosis, or severe stress, occurred within 1 month before screening;
7. Patients with serious illnesses whose life expectancy does not exceed 2 years, or malignant tumor, or mental diseases.
8. Patients who are known to be allergic to the ingredients in SQXT formula or its preparations;
9. Having a history of alcoholism or drug abuse;
10. Women who are preparing for pregnancy, or pregnant, or lactating women.

Study & Design

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