The efficacy and safety of chinese herbal medicine Shen-Qi Hua-Yu formula in patients with diabetic lower extremity artery disease: a multi-centre, randomized, double-blind, placebo-controlled trial

An optimized clinical treatment strategy and its mechanisms for Shen-Qi Sequential Therapy in the prevention and treatment of Diabetic Macrovascular Diseases based on the TCM theory of Latent Pathogen

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900026372

Enrollment

Unknown

Registered

2019-10-04

Start date

2020-08-20

Completion date

Unknown

Last updated

2020-09-07

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

Conditions

Diabetic Lower Extremity Artery Disease

Interventions

the placebo group:placebo

the treatment group:SHENQI-HUA-YU formula

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: To be included in the study, patients must have: (1) Voluntarily participate in the test and sign the informed consent; (2) Aged between 18 and 80 years; (3) Those who meet the criteria of diagnosis and staging of diabetic lower extremity vascular disease in stage I, II A, II B, III and TCM diagnostic criteria ; (4) Women of childbearing age are required negative pregnancy test and agree to use reliable contraception measures during the study;

Exclusion criteria

Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: (1) Patients with cardiac insufficiency, EGFR < 60 ml · min-1, acute coronary syndrome, cerebrovascular accident, vasculitis, venous insufficiency of lower extremity, fracture and osteoarthritis, hematopoiesis and mental disease; (2) Patients with acute metabolic disorders such as diabetic ketoacidosis within the past 1 month; (3) Pregnant and 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; (8) The blood glucose in the lead-in period did not meet the standard; (9) Patients considered by the investigator to be unfit for this study.

Design outcomes

Primary

Measure	Time frame
Ankle brachial index;The inner diameter of the anterior tibial artery, posterior tibial artery and dorsalis pedis artery;The peak systolic velocity of the anterior tibial artery, posterior tibial artery and dorsalis pedis artery;The end diastolic velocity of the anterior tibial artery, posterior tibial artery and dorsalis pedis artery;The mean average velocity of the anterior tibial artery, posterior tibial artery and dorsalis pedis artery;	—

Measure

Time frame

Ankle brachial index;The inner diameter of the anterior tibial artery, posterior tibial artery and dorsalis pedis artery;The peak systolic velocity of the anterior tibial artery, posterior tibial artery and dorsalis pedis artery;The end diastolic velocity of the anterior tibial artery, posterior tibial artery and dorsalis pedis artery;The mean average velocity of the anterior tibial artery, posterior tibial artery and dorsalis pedis artery;

—

Secondary

Measure	Time frame
Fasting plasma glucose;Blood lipid;Hemorheology indexes;Advanced glycation end products;TCM syndrome score;glycosylated hemoglobin;	—

Countries

China

Contacts

Public ContactChunguang Xie

Hospital of Chengdu University of Traditional Chinese Medicine

xcg899@163.com+86 028-87783242

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026