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Clinical research of Qidan Dihuang granule combined with ACEI/ARB on patients with early-stage diabetic nephropathy

Optimization of treatment protocols for diabetic nephropathy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-12002756
Enrollment
Unknown
Registered
2012-10-30
Start date
2011-06-01
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 nephropathy

Interventions

Observation Group:Qidan Dihuang granule combined with ACEI/ARB

Sponsors

Southern Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients included in the study were diagnosed with type 2 diabetes mellitus; (2) Patients included in the study were diagnosed with early-stage diabetic nephropathy; (3) The age of patients are between 18-80 years; (4) HbA1c<=12.5%, fasting plasma glucose<=7.8mmol/L or 2-hour postprandial blood glucose <11mmol/L after diet control, exercise therapy or taking hypoglycemic medicine for one week; (5) The value of eGFR is between 80 and 120ml/min (according to the modified MDRD formula); (6) Patients voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients did not meet the diagnostic criteria of early diabetic nephropathy; (2) Patients suffered from coronary heart disease, myocardial infarction, severe mental disorders,severe arrhythmia and other serious complications of liver, kidney and hematopoietic system (blood pressure was over 160/90mmHg; the ALT rised above 1.5 times of the upper limit of normal value; BUN and Cr were above the normal range); (3) Fasting plasma triglyceride was above l0mmol/L(>886mg/d1); (4) Patients with type 2 diabetes mellitus were diagnosed with diabetic ketoacidosis or diabetic hyperosmolar coma; (5) Patients had a variety of infections in 4 weeks; (6) The age of patients is younger than 18 years, or older than 80 years; (7) Patients were pregnant or lactating women; (8) Patients were allergic to the test drug; (9) Patients were subjects of clinical trials of other drugs; (10) The researchers thought the patients were not suitable for clinical subjects for other reasons.

Design outcomes

Primary

MeasureTime frame
Urine microalbumin excretion rate;

Secondary

MeasureTime frame
fasting blood glucose;2-hour postprandial blood glucose;Glycosylated hemoglobin;blood lipids;

Countries

China

Contacts

Public ContactRen Luo
luoren41671@yahoo.com.cn+86 13503049569

Outcome results

None listed

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