Abelmoschus manihot – a traditional Chinese medicine versus losartan potassium for treating IgA nephropathy: study protocol for a randomized controlled trial
| العنوان: | Abelmoschus manihot – a traditional Chinese medicine versus losartan potassium for treating IgA nephropathy: study protocol for a randomized controlled trial |
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| المؤلفون: | Hongli Lin, Nian-song Wang, Rong Wang, Ping Li, Yizhi Chen, Xuefeng Sun, Jing-Ai Fang, Zhaohui Ni, Xiangmei Chen, Hong-tao Yang, Yongli Zhan, Wenge Li |
| المصدر: | Trials, Vol 18, Iss 1, Pp 1-8 (2017) Trials |
| بيانات النشر: | BMC, 2017. |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | 030232 urology & nephrology, Medicine (miscellaneous), 030204 cardiovascular system & hematology, urologic and male genital diseases, law.invention, chemistry.chemical_compound, Study Protocol, 0302 clinical medicine, Randomized controlled trial, Clinical Protocols, law, Randomized controlled study, Outcome Assessment, Health Care, Pharmacology (medical), Prospective Studies, Medicine, Chinese Traditional, lcsh:R5-920, Proteinuria, Traditional medicine, biology, IgA nephropathy, Middle Aged, medicine.symptom, lcsh:Medicine (General), Adult, medicine.medical_specialty, Adolescent, Renal function, Losartan, Nephropathy, 03 medical and health sciences, Young Adult, Traditional Chinese medicine, Double-Blind Method, Abelmoschus, Internal medicine, medicine, Humans, Abelmoschus manihot, Aged, Creatinine, business.industry, Glomerulonephritis, IGA, medicine.disease, biology.organism_classification, Clinical trial, chemistry, business, Angiotensin II Type 1 Receptor Blockers, Kidney disease |
| الوصف: | Background IgA nephropathy (IgAN) is one of the most common primary glomerular diseases worldwide, but effective therapy remains limited and many patients progress to end-stage renal disease (ESRD). Only angiotensin-converting enzyme inhibitors (ACE-I)/angiotensin-receptor blockers (ARB) show a high level of evidence (1B level) of being of value in the treatment for IgAN according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. However, traditional Chinese medicine has raised attention in kidney disease research. Abelmoschus manihot, a single medicament of traditional Chinese medicine has shown therapeutic effects in primary glomerular disease according to the randomized controlled clinical trial that we have completed. Here, we conduct a new study to assess the efficacy and safety of Abelmoschus manihot in IgAN. Also, this study is currently the largest double-blind, randomized controlled registered clinical research for the treatment of IgAN. Methods We will conduct a multicenter, prospective, double-blind, double-dummy randomized controlled study. The study is designed as a noninferiority clinical trial. Approximately 1600 biopsy-proven IgAN patients will be enrolled at 100 centers in China and followed up for as long as 48 weeks. IgAN patients will be randomized assigned to the Abelmoschus manihot group (in the form of a huangkui capsule, 2.5 g, three times per day) and the losartan potassium group (losartan potassium, 100 mg/d). The primary outcome is the change in 24-h proteinuria from baseline after 48 weeks of treatment. Change in estimated glomerular filtration rate (eGFR) from baseline after 48 weeks of treatment, the incidence of endpoint events (proteinuria ≥3.5 g/24 h, the doubling of serum creatinine, or receiving blood purification treatment) are the secondary outcomes. Twenty-four-hour proteinuria and eGFR are measured at 0, 4, 12, 24, 36 and 48 weeks. Discussion This study will be of sufficient size and scope to evaluate the efficacy and safety of Abelmoschus manihot compared to losartan potassium in treating patients with IgAN. The results of this study may provide a new, effective and safe treatment strategy for IgAN. Trial registration ClinicalTrials.gov, identifier: NCT02231125. Registered on 30 August 2014. Electronic supplementary material The online version of this article (doi:10.1186/s13063-016-1774-6) contains supplementary material, which is available to authorized users. |
| اللغة: | English |
| تدمد: | 1745-6215 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::47eaa64c6ff2a42ae08a669f3f901df2Test http://link.springer.com/article/10.1186/s13063-016-1774-6Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....47eaa64c6ff2a42ae08a669f3f901df2 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 17456215 |
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