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Study on Efficacy and Safety of Treatment with Compound Danshen Dripping Pills (CDDP) in Type 2 diabetes

Study on Efficacy and Safety of Treatment with Compound Danshen Dripping Pills (CDDP) in Type 2 diabetes

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12001975
Enrollment
Unknown
Registered
2012-02-29
Start date
2012-03-01
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

diabetic retinopathy and / or diabetic nephropathy.

Interventions

Control:Conventional treatment, not taking the compound Danshen Dripping Pill

Sponsors

Shengjing Hospital of China Medical University, and Affiliated Hospital of Liaoning University of Chinese Traditional Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 75 Years

Inclusion criteria

Inclusion criteria: The patient should meet the 1st to 4th criteria at the same time. And DR group must also satisfy the 5th criteria, DN group must meet 6th and 7th criteria. Patients who meet 8th criteria could enter either DR or DN group. 1. Diagnosed type 2 diabetic patients according to WHO standard in 1991; 2. Age range: 25-75, male or female; 3. Blood glucose and blood pressure should be under good control: HbA1c <9%, BP <140mmHg/90mmHg; serum lipid level is normal. Blood glucose and blood pressure in a normal range at least for half a month; 4. If the blood pressure, blood glucose or blood lipid is not meet the third criteria, allowing for half a month after the screening period; 5. Diabetic retinopathy (stage II ~ III microaneurysms, hemorrhage spot, yellow and white exudate, or macular edema); 6. DN group who have hypertension must use the ACEI or ARB agents for more than 2 weeks to control blood pressure; 7. DN group (phase III; the ratio of urine microalbumin to creatinine: 30 to 300 mg/g); 8. Both have diabetic retinopathy and diabetic nephropathy.

Exclusion criteria

Exclusion criteria: 1. Allergic to CDDP; 2. Severe hepatic impairment ( ALT, AST or TBil is higher than the limit of normal value of 3 times, allowing retest in one week later); 3. Severe heart disease, myocardial infarction, unstable angina, chronic heart failure (NYHA grade III and IV); 4. Severe renal impairment (Cr is higher than the limit of normal value of one time, allowing retest in one week later); 5. Mental disease or cognitive impairment patients; 6. Pregnant and lactating women, and women without normal contraceptive measures during the study period; 7. Urinary infection (urine routine test: WBC>=10/HP), and the infection still exist in two weeks later (urine routine test: WBC>=10/HP); 8. Participated (within three months) in or are in other clinical trials; 9. Patients could not take medicine on time; 10. Other reasons not for clinical trials.

Design outcomes

Primary

MeasureTime frame
urine microalbumin / (creatinine);Microhemangioma;Bleeding sopt;The visual acuity;hard (soft) exudate;

Secondary

MeasureTime frame
Blood glucose;Blood pressure;HbA1c;

Countries

China

Contacts

Public ContactHan Ping, Yu Shijia
hanping85@hotmail.com+86 18940251110

Outcome results

None listed

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