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

• Published in: Trials Vol. 14; no. 1; p. 223
• Main Authors: Tu, Xiang, Liu, Fang, Jordan, James B, Ye, Xue Feng, Fu, Ping, Wang, Fei, Zhong, Sen
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 18.07.2013; BioMed Central
• Subjects: Administration, Oral; Albumin; Angiotensin converting enzyme; Astragalus (Plants); Astragalus Plant - adverse effects; Biomarkers - blood; Biomarkers - urine; Blood Glucose - metabolism; Care and treatment; China; Clinical Protocols; Complications and side effects; Creatinine - blood; Creatinine - urine; Diabetes therapy; Diabetic nephropathies; Diabetic Nephropathies - blood; Diabetic Nephropathies - diagnosis; Diabetic Nephropathies - drug therapy; Diabetic Nephropathies - physiopathology; Diabetic Nephropathies - urine; Drugs, Chinese Herbal - administration & dosage; Drugs, Chinese Herbal - adverse effects; Drugs, Chinese Herbal - therapeutic use; Glomerular Filtration Rate - drug effects; Glycated Hemoglobin A - metabolism; Health aspects; Humans; Medicine, Chinese; Pilot Projects; Proteinuria; Proteinuria - blood; Proteinuria - diagnosis; Proteinuria - drug therapy; Proteinuria - physiopathology; Proteinuria - urine; Research Design; Study Protocol; Time Factors; Treatment Outcome; China
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/1745-6215-14-223

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