Clinical research of liu wei di huang pill combined with ACEI/ARB on patients with early-stage diabetic nephropathy

Optimization of treatment protocols for diabetic nephropathy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12002401

Enrollment

Unknown

Registered

2012-07-04

Start date

2010-12-01

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:liu wei di huang pill combined with ACEI/ARB

Control Group:ACEI/ARB

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

Measure	Time frame
Urine microalbumin excretion rate;	—

Secondary

Measure	Time 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