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Open Access Study protocol

‘Huang Qi Elixir’ for proteinuria in patients with diabetic nephropathy: a study protocol for a randomized controlled pilot trial

Xiang Tu1, Fang Liu2, James B Jordan3, Xue Feng Ye4, Ping Fu2, Fei Wang5 and Sen Zhong1*

Author Affiliations

1 National Traditional Chinese Medicine Clinical Research Base/Teaching Hospital of Chengdu University of Traditional Chinese Medicine (Traditional Chinese Medicine Hospital of Sichuan Province), Chengdu, Sichuan Province 610072, China

2 Division of Nephrology, West China Hospital of Sichuan University, Chengdu, Sichuan Province 610041, China

3 Private Practice, 453 Cerrillos Rd., Bldg. E, Santa Fe, NM 87501, USA

4 Department of Nephrology, Teaching Hospital of Chengdu University of Traditional Chinese Medicine (Traditional Chinese Medicine Hospital of Sichuan Province), Chengdu, Sichuan Province 610072, China

5 Department of Gerontology, Teaching Hospital of Chengdu University of Traditional Chinese Medicine (Traditional Chinese Medicine Hospital of Sichuan Province), Chengdu, Sichuan Province 610072, China

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Trials 2013, 14:223  doi:10.1186/1745-6215-14-223

Published: 18 July 2013

Abstract

Background

Diabetic nephropathy (DN) is the major complication of diabetes; proteinuria is the hall mark of DN. Currently, the treatment for proteinuria is mainly limited to angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). According to Traditional Chinese Medicine (TCM) theory, Chinese medicinals ‘securing essence and tonifying the kidney’ may be appropriate for proteinuria. The most promising Chinese medicinals and formulae are introduced in the present study to form a potent formula for DN proteinuria. To make oral administration convenient, the formula will be processed in the form of granules.

Methods/design

A randomized, multi-center pilot trial will be conducted. Forty eight participants with DN will be randomly assigned to one of four treatment groups:

1. A granule group, at 10 grams, three times daily (G10 group, n = 12);

2. A granule group, at 20 grams, three times daily (G20 group, n = 12);

3. A decoction group (D group, n = 12); and

4. An irbesartan group (Aprovel group, n = 12).

The following outcome measures will be used: the percentage change of the albumin-to-creatinine ratio; and the changes in serum creatinine, glomerular filtration rate, fasting plasma glucose and hemoglobulin from baseline to the end of the trial.

Discussion

It is notable that most published clinical trials which assessed the efficacy of TCM on DN were of poor methodology and, therefore, their results have been invalidated. It is necessary to carry out well-designed clinical trials to provide sound evidence. The present trial is a study with potentially great value, for it will provide the parameters for future randomized, placebo-controlled, clinical trials with large sample sizes.

Trial registration

The trial is registered on the Chinese Clinical Trial Registry: ChiCTR-TRC-12002718 (http://www.chictr.org/cn/proj/show.aspx?proj=3820 webcite).

Keywords:
Traditional Chinese Medicine; Huang Qi Elixir; Diabetic nephropathy; Proteinuria; Clinical trials; Pilot trial