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Clinical Study of Diabetic Nephropathy Integrative Intervention

Clinical Study on the Stage Treatment of Diabetic Nephropathy with Therapy of Traditional Chinese and Western Medicine

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13004012
Enrollment
Unknown
Registered
2013-12-08
Start date
2014-01-01
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

Shanghai Municipal Health Bureau

Interventions

DN-CKD1:Fundamental intervention (behavioral interventions, glycemic control, lipid control, blood pressure control)+Vasarltan 80mg Qd P.O.+Yi Shen Gu Jing granules or placebo
DN-CKD2~3:Fundamental intervention (behavioral interventions, glycemic control, lipid control, blood pressure control)+Vasarltan 80mg Qd P.O.+Yi Shen Xie Zhuo granules or placebo

Sponsors

Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Comply with the diagnostic criteria of diabetic nephropathy; 2. Aged 18 to 70 years old; 3. eGFR> 30ml/min/1.73m2; 4. Sign the inform consent.

Exclusion criteria

Exclusion criteria: 1. Previous history of non-diabetic nephropathy; 2. Nephritis Urine (abnormal red blood cells in urine); 3. Severe renal failure eGFR evaluated as the stage of CKD4-5; 4. Unilateral or bilateral renal artery stenosis; 5. Poorly controlled blood pressure, SBP> 160mmHg, or DBP> 100mmHg patients; 6. Myocardial infarction, heart failure or unstable angina pectoris; 7. History of stroke; 8. Liver damage, ALT or AST> 2-fold; 9. Pregnant or lactating; 10. Mental disease; 11. Cancer patients; 12. Allergic to the test drugs or ingredients of the T.C.M. granules;

Design outcomes

Primary

MeasureTime frame
The incidence of endpoint events:Dialysis, doublin;UMA;24-hour urinary protein excretion;Serum creatinine;eGF;

Secondary

MeasureTime frame
BMI;Waist / hip;Blood pressure;TCM syndrome score;Serum Uric acid;Fasting plasma glucose;Glycated hemoglobin;

Countries

China

Contacts

Public ContactWang Yi

Yueyang Hospital of Integrated Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

drwangyi0110@126.com+86 18930560215

Outcome results

None listed

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