Clinical evaluation of Tangzu granule in the treatment of high-risk foot of diabetes

Clinical evidence-based evaluation of Traditional Chinese Medicine for prevention and treatment of diabetic high-risk foot

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2200006534

Enrollment

Unknown

Registered

2022-08-24

Start date

2022-08-25

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

High risk foot of diabetes

Interventions

Oral control group:basic treatment+Oral placebo

Fotting treatment group:basic treatment+footting with Tangzu granule

Fotting control group:basic treatment+footting with placebo

Oral treatment group:basic treatment+Oral Tangzu granule

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for type 2 diabetes defined in the "Guideline for the prevention and treatment of type diabetes mellitus in China (2020 edition)"; 2.Meet the diagnostic criteria for high-risk foot for diabetes; 3.Age between 18 and 80 years old, regardless of gender; 4.Voluntarily participate in this trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with typical diabetic foot symptoms such as foot ulcers, infections, and gangrene; 2.There are other diseases that cause damage to peripheral nerves and blood vessels; 3.Mentally ill patients; 4.Combined with serious heart, brain, kidney and other complications, or combined with other serious primary diseases; 5.Those who have a history of allergies or allergies to drugs, food, pollen, etc.; 6.Pregnant, lactating women and women planning to become pregnant; 7.Those who use hormones and undergo surgical treatment and other stressful states of the body; 8.Patients with acute diabetic complications such as ketoacidosis and hyperosmolarity and concurrent infections; 9.Patients who use antioxidant drugs (such as lipoic acid), anti-platelet aggregation drugs (such as aspirin enteric-coated tablets), Chinese patent medicines and other nerve and vascular disease prevention drugs and nutritional nerve preparations (such as methylcobalamin); 10.Those who have participated in other clinical trials within three months. Note: Patients who meet any of the above should be excluded.

Design outcomes

Primary

Measure	Time frame
ankle/ branchial index;Toronto clinical scoring system;nerve conduction velocity;local symptom scale;	—

Secondary

Measure	Time frame
lower extremity ultrasound;blood lipids;EQ-5D-5L Quality of Life Evaluation Form;Infrared thermal imaging;VAS;hemorheology;	—

Countries

China

Contacts

Public ContactMa Xitao

Hospital of Chengdu University of TCM

maxitao@cdutcm.edu.cn134 3833 7403

Outcome results

None listed

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