‘Huang Qi Elixir’ for proteinuria in patients with diabetic nephropathy: a study protocol for a randomized controlled pilot trial
| Autor: | Fang Liu, Ping Fu, Sen Zhong, Xue Feng Ye, Fei Wang, Xiang Tu, James B. Jordan |
|---|---|
| Rok vydání: | 2013 |
| Předmět: |
Blood Glucose
China medicine.medical_specialty Time Factors Urology Administration Oral Medicine (miscellaneous) Renal function Pilot Projects Diabetic nephropathy Traditional Chinese medicine law.invention Huang Qi Elixir Study Protocol chemistry.chemical_compound Clinical trials Clinical Protocols Randomized controlled trial law Internal medicine Diabetes mellitus medicine Traditional Chinese Medicine Humans Diabetic Nephropathies Pharmacology (medical) Glycated Hemoglobin Creatinine Proteinuria biology business.industry Angiotensin-converting enzyme Astragalus Plant Astragalus propinquus medicine.disease Pilot trial Treatment Outcome Endocrinology chemistry Research Design biology.protein medicine.symptom business Biomarkers Drugs Chinese Herbal Glomerular Filtration Rate |
| Zdroj: | Trials |
| ISSN: | 1745-6215 |
| DOI: | 10.1186/1745-6215-14-223 |
| Popis: | 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). |
| Databáze: | OpenAIRE |
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