To Compare the Efficacy and Safety of Tripterygium (TW) Versus Valsartan in the Diabetic Nephropathy (DN)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-03-31

Brief Summary

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The purpose of this study is to compare the efficacy and safety of Tripterygium (TW) versus Valsartan (ARB) in the Diabetic Nephropathy (DN).

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Detailed Description

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Diabetic nephropathy with heavy proteinuria have high risks of progressing to end stage renal disease. Though recent studies have shown that ACEI or ARB could reduce proteinuria of DN and slowed the progression to ESRD. But ARBs can only reduce proteinuria about 30%, so some patients still have heavy proteinuria,and then loss their renal function rapidly. So, to reduce the proteinuria of DN is a very important therapy target.

Tripterygium (TW) is a Chinese traditional patent drug, it can reduce proteinuria of chronic glomerular nephritis. So, we designed this randomized, prospective clinical trial to assess the efficacy and safety of TW versus ARB in the treatment of heavy proteinuria of DN.

Conditions

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Diabetic Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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immunosuppressor

Valsartan,160mg/d,TW 120mg/d

Group Type EXPERIMENTAL

TW

Intervention Type DRUG

TW,120 mg/d

Interventions

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TW

TW,120 mg/d

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. A new diagnosis of diabetic nephropathy proved by histology and(or) serology.
2. Proteinuria \> 2.5 g/24 h
3. serum creatinine \< 3 mg/dl
4. age 35-65 years

Exclusion Criteria

1. Co-existence of anther chronic glomerular nephritis.
2. Severe disfunction of the liver
3. White blood cell \< 3000/ul
4. Severe infection in the past 1 month
5. Malignant hypertension which in hard to control
6. Myocardial infarct or heart failure or sever cerebral vessels complication in the past 6 month

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No