A randomized, double-blind, parallel controlled clinical trial of Danzhijiangtang capsule in the treatment of type 2 diabetes vascular lesions with Qi-Yin deficiency and blood stasis syndrome

A clinical research of Xin’an Medicine in the prevention and treatment of Xiaoke disease (Diabetes Mellitus)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-13003533

Enrollment

Unknown

Registered

2013-07-24

Start date

2013-02-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

Type 2 Diabetes Mellitus

Interventions

Control group:melbine+glimepiride+atorvastatin

Treatment group:melbine+glimepiride+atorvastatin+Danzhijiangtang Capsule

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus and conform to Traditional Chinese Medicine diagnostic criteria with Qi-Yin deficiency and blood stasis syndrome.Course of disease more than 3 months; 2. Aged from 18 to 70 years; 3. Fasting plasma glucose in 7.0-13.9mmol/L and/or 2-hour postprandial plasma glucose in 11.1-22.0mmol/L after disabling existing antidiabetic drugs; 4. Neck vascular ultrasound prompted artery intima-media thickening, atherosclerotic plaque or thrombus forma-tion; 5. Electrocardiogram result is normal sinus rhythm; 6. No recent birth plan and agreed to take effective contraceptive measures during the study period; 7. Voluntarily participate in the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. Although blood glucose is higher than normal, but after diet control, exercise therapy, or after treatment w-ith antidiabetic medicine, blood glucose testing diagnostic value dropped to less; 2. In pregnancy,lactation or have a recent birth plan; 3. Duration of diabetes in three months or less; 4. Within the past month have diabetic ketoacidosis and other metabolic disorders as well as patients with severe infection; 5. Patients with severe heart disease, cerebrovascular disease, vascular interventional surgery, severe arrhythmia, cancer, liver, kidney, hematopoietic system and other serious primary disease; 6. Chronic alcoholics, drug addicts, patients with mental illness; 7. Suffering from severe indigestion, or gastrointestinal tract and other gastrointestinal diseases that can affect the drug absorption; 8. Danzhijiangtang Capsule prescription for allergy or allergy itself; 9. Participated in other clinical trials within 3 months.

Design outcomes

Primary

Measure	Time frame
Carotid intima-media thickness,CIM;	—

Secondary

Measure	Time frame
TCM symptoms of diabetes grade quantitative score;thrombomodulin, TM;FPG and 2hPG;TG, TC, HDL-C and LDL-C;HbA1c;insulin and C-peptid;	—

Countries

China

Contacts

Public ContactZhaohui Fang

The first affiliated hospital of Anhui university of Chinese medicine

fangzhaohui@medmail.com.cn+86 0551-62850092

Outcome results

None listed

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