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

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR1900002645

Enrollment

Unknown

Registered

2019-10-04

Start date

2019-10-10

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 Lower Extremity Artery Disease

Interventions

the treatment group:SHENQI-HUA-YU formula

the placebo group:placebo

Eligibility

Sex/Gender

All

Age

35 Years to 75 Years

Inclusion criteria

Inclusion criteria: To be included in the study, patients must have: (1) Diagnosis of LEAD of diabetes as well as Qi-yin deficiency with blood stasis syndrome according to WM and TCM; (2) According to Fontaine stage of LEAD, patients with stage I, IIa and IIb are eligible; (3) Aged between 35 and 75 years; (4) HbA1c <= 9.0%; (5) Women of childbearing age are required negative pregnancy test and agree to use reliable contraception measures during the study; (6) Voluntarily participate in the test and sign the informed consent;

Exclusion criteria

Exclusion criteria: Patients will be excluded from the study if they meet any of the following criteria: (1) Patients with cardiac and renal insufficiency, acute coronary syndrome, cerebrovascular accident, vasculitis, venous dysfunction of lower limbs, hematopoietic system disorders and mental diseases; (2) Patients with acute metabolic disorders such as diabetic ketoacidosis within the past 1 month; (3) Severe infection in the past 1 month; (4) Patients with allergic constitution; (5) Uncooperative in run-in period; (6) Having a history of alcoholism or drug abuse; (7) A history of another clinical study in the previous 3 months; (8) Patients considered by the investigator to be unfit for this study.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

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

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