title: 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.
abstract: 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Tianjin Institute of Clinical Evaluation, Tianjin University of TCM, 88 Yuquan Street, Nankai District, Tianjin 300193, China.
authors.forename: Hui
authors.initials: H
authors.lastname: Wang
authors.forename: Wei
authors.initials: W
authors.lastname: Mu
authors.forename: Jingbo
authors.initials: J
authors.lastname: Zhai
authors.forename: Dongmei
authors.initials: D
authors.lastname: Xing
authors.forename: Shujie
authors.initials: S
authors.lastname: Miao
authors.forename: Jia
authors.initials: J
authors.lastname: Wang
authors.forename: Yueyi
authors.initials: Y
authors.lastname: Deng
authors.forename: Niansong
authors.initials: N
authors.lastname: Wang
authors.forename: Hongyu
authors.initials: H
authors.lastname: Chen
authors.forename: Hongtao
authors.initials: H
authors.lastname: Yang
authors.forename: Xuehong
authors.initials: X
authors.lastname: He
authors.forename: Hongcai
authors.initials: H
authors.lastname: Shang
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use; D015415:Biomarkers / Q000097:blood / Q000652:urine; D001713:Biphenyl Compounds / Q000627:therapeutic use; D002681:China; D002985:Clinical Protocols; D003404:Creatinine / Q000097:blood / Q000652:urine; D003928:Diabetic Nephropathies / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000652:urine; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D000077405:Irbesartan; D008297:Male; D008875:Middle Aged; D011507:Proteinuria / Q000188:drug therapy / Q000652:urine; D012107:Research Design; D012720:Severity of Illness Index; D013607:Tablets; D013777:Tetrazoles / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D015415:Biomarkers; D001713:Biphenyl Compounds; D004365:Drugs, Chinese Herbal; D013607:Tablets; D013777:Tetrazoles; C583767:shenyan kangfu; D003404:Creatinine; D000077405:Irbesartan