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Clinical Investigation of Composite Danshen Pill for the Treatment of Type 2 diabetes angiopathy

Clinical Investigation of Composite Danshen Pill for the Treatment of Type 2 diabetes angiopathy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006501
Enrollment
Unknown
Registered
2015-06-04
Start date
2015-07-01
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

diabetes

Interventions

The treatment group :Standard treatment + Composite Danshen Pill 10 / times three times a day orally
Control Group :Standard therapy plus aspirin enteric-coated tablets 100mg / time orally once daily

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. 1999 WHO criteria for diagnosis of type 2 diabetes; 2. Age range 40 to 75 years; 3. Glycated hemoglobin> 6% but =40 years of age, there is involvement of coronary, cerebrovascular or peripheral vascular system of atherosclerosis-related clinical events; The Standard of multiple risk factors: age (men >=55 years, women >=60 years), at least one of the following additional risk factors: dyslipidemia, hypertension, or active smoking.

Exclusion criteria

Exclusion criteria: 1. The patients who are hypersensitive to the components of the CSDP or aspirin; 2. The patients who have diabetic ketoacidosis and severe cardiovascular and cerebrovascular diseases and other major adverse events occurred within six months; 3. Severe liver and kidney disease; 4. The patients who have active peptic ulcer or gastrointestinal bleeding; 5. Mental disorders or cognitive disorders; 6. Pregnant and lactating women, women of childbearing age who do not agree to take contraceptive measures during the trial; 7. The patients who are participating in other clinical trials; 8. The patients who can not take medication on time; 9. The patients that researchers believe not suitable for clinical trials.

Design outcomes

Primary

MeasureTime frame
Urine albumin;urine creatinine;Carotid ultrasound;

Secondary

MeasureTime frame
Cardiovascular and cerebrovascular events;

Countries

China

Contacts

Public ContactLU Hao
luhao403@163.com+86 13916719260

Outcome results

None listed

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