The key role of Shenyan Kangfu tablets, a Chinese patent medicine for diabetic nephropathy: study protocol for a randomized, double-blind and placebo-controlled clinical trial

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• 作者：Hui Wang (22)
  Wei Mu (22)
  Jingbo Zhai (22)
  Dongmei Xing (22)
  Shujie Miao (23)
  Jia Wang (23)
  Yueyi Deng (24)
  Niansong Wang (25)
  Hongyu Chen (26)
  Hongtao Yang (27)
  Xuehong He (28)
  Hongcai Shang (22)
  
• 关键词：Shenyan Kangfu tablets ; Efficacy ; Safety ; Diabetic nephropathy ; Randomized controlled trial
• 刊名：Trials
• 出版年：2013
• 出版时间：December 2013
• 年：2013
• 卷：14
• 期：1
• 全文大小：263KB
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• 作者单位：Hui Wang (22)
  Wei Mu (22)
  Jingbo Zhai (22)
  Dongmei Xing (22)
  Shujie Miao (23)
  Jia Wang (23)
  Yueyi Deng (24)
  Niansong Wang (25)
  Hongyu Chen (26)
  Hongtao Yang (27)
  Xuehong He (28)
  Hongcai Shang (22)
  
  22. Tianjin Institute of Clinical Evaluation, Tianjin University of TCM, 88 Yuquan Street, Nankai District, Tianjin, 300193, China
  23. Tianjin Tongrentang Group Co, Ltd, Machang Street, Hexi District, Tianjin, 300132, China
  24. Department of Nephrology, Longhua Hospital of Shanghai University of TCM, 725 South Wanping Road, Shanghai, 200032, China
  25. Department of Nephrology and Rheumatology, The Sixth People鈥檚 Hospital of Shanghai, 600 Yishan Road, Shanghai, 200233, China
  26. Department of Nephrology, Guangxing Hospital Affiliated to Zhejiang University of TCM, Tiyuchang Road, Hangzhou, 310007, China
  27. Department of Nephrology, The First Affiliated Hospital of Tianjin University of TCM, 314 West Anshan Road, Nankai District, Tianjin, 300193, China
  28. Department of Nephrology, Affiliated Hospital of Liaoning University of TCM, 33 Beiling Street, Huangu District, Shenyang, 110032, China
  

文摘

Background Diabetic nephropathy (DN) is a major microvascular complication with diabetes. In China, an estimated 34.7 percent of people diagnosed with diabetes have renal complications and a further 50 percent die of renal failure. Hence, identification of alternative treatments for these patients should be given priority. The Shenyan Kangfu tablet (SYKFT) is a new formulation of an existing and widely acclaimed Chinese herbal tea for treating qi-yin deficiency syndrome. Because a considerable portion of DN patients presenting with symptoms of swelling, fatigue and weak limbs would be diagnosed with qi-yin deficiency syndrome according to the traditional Chinese medicine (TCM) diagnostic criteria, we hypothesize that SYKFT may represent a complementary drug for DN patients with the corresponding syndrome. In view of this, we have designed a trial to assess the efficacy and safety of SYKFT for patients with diabetic nephropathy exhibiting signs of qi and yin deficiency. Methods This is a multicenter, double-blind, randomized controlled trial (RCT). The total target sample size is planned at 80 participants, with a balanced (1:1) treatment allocation. The experimental intervention will be SYKFY plus irbesartan (SI regimen) and the control intervention will be a placebo plus irbesartan (PI regimen). Participants will receive two courses of medication treatment each lasting 8 weeks. The primary outcome will be the composite of the quantitative 24-hour urinary protein level and urinary albumin excretion rate (UAER). Changes in urine albumin-to-creatinine ratio (UACR) and DN staging, and TCM symptom improvement will be the secondary outcome measures. Adverse events (AEs) will be monitored throughout the trial. Discussion This study will be the first placebo-controlled RCT to assess whether SYKFT plus irbesartan will have beneficial effects on enhancing overall response rate (ORR), changing DN staging, improving clinical symptoms, and reducing the frequency of AEs for DN patients with qi-yin deficiency syndrome. The results of this trial will help to provide evidence-based recommendations for clinicians. Trial registration Chinese Clinical Trials Register, Identifier: ChiCTR-TRC-12002182