title: Chinese herbal medicine Tangshen Formula treatment of patients with type 2 diabetic kidney disease with macroalbuminuria: study protocol for a randomized controlled trial.
abstract: Diabetic kidney disease (DKD) is one of the most common microvascular complications of diabetes mellitus and the main cause of end-stage renal disease. Present medications for DKD are not entirely satisfactory. Preliminary studies indicate that the Chinese herbal formula Tangshen Formula (TSF) appears to decrease the proteinuria and improve the estimated glomerular filtration rate (eGFR) in DKD patients.
  
  
  
  This trial is a five-center, randomized, double-blind, placebo-controlled study. DKD patients with a 24-h urinary protein (24 h UP) level between 0.5 and 3.5 g and serum creatinine < 265 μmol/L (3 mg/dl) will be included. A sample size of 144 participants will be randomly distributed into the treatment group (TSF plus irbesartan) and the control group (placebo plus irbesartan) at a ratio of 1:1. The study duration will be 50 weeks, comprising a 2-week run-in period, 24 weeks of intervention, and 24 weeks of follow-up. The primary endpoint will be the 24 h UP. Secondary endpoints will be an evaluation of renal function, management of blood lipids, improvement in traditional Chinese medicine symptoms, and safety assessments. Adverse events will also be evaluated.
  
  
  
  This study will provide evidence for the effectiveness and safety of TSF compared to placebo in treating DKD patients with macroalbuminuria.
  
  
  
  Chinese Clinical Trials Registry, ChiCTR-TRC-13003566 . Registered 9 August 2013.
authors.affiliation: Beijing Key Lab for Immune-Mediated Inflammatory Diseases, Institute of Clinical Medical Science, China-Japan Friendship Hospital, 2 East Yinghua Road, Chaoyang District, Beijing, 100029, China.
authors.forename: Meihua
authors.initials: M
authors.lastname: Yan
authors.affiliation: Beijing Key Lab for Immune-Mediated Inflammatory Diseases, Institute of Clinical Medical Science, China-Japan Friendship Hospital, 2 East Yinghua Road, Chaoyang District, Beijing, 100029, China.
authors.forename: Yumin
authors.initials: Y
authors.lastname: Wen
authors.affiliation: Department of Nephrology, Guang'anmen Hospital of China Academy of Traditional Chinese Medical Sciences, 5 Beixiange, Xicheng District, Beijing, 100053, China.
authors.forename: Liping
authors.initials: L
authors.lastname: Yang
authors.affiliation: Beijing Key Lab for Immune-Mediated Inflammatory Diseases, Institute of Clinical Medical Science, China-Japan Friendship Hospital, 2 East Yinghua Road, Chaoyang District, Beijing, 100029, China.
authors.forename: Xi'ai
authors.initials: X
authors.lastname: Wu
authors.affiliation: Department of Nephrology, Guang'anmen Hospital of China Academy of Traditional Chinese Medical Sciences, 5 Beixiange, Xicheng District, Beijing, 100053, China.
authors.forename: Xiaoguang
authors.initials: X
authors.lastname: Lu
authors.affiliation: Beijing Key Lab for Immune-Mediated Inflammatory Diseases, Institute of Clinical Medical Science, China-Japan Friendship Hospital, 2 East Yinghua Road, Chaoyang District, Beijing, 100029, China.
authors.forename: Bingxuan
authors.initials: B
authors.lastname: Zhang
authors.affiliation: Beijing Qihuang Drug Clinical Research Center, 9 Guang'an Road, Fengtai District, Beijing, 100055, China.
authors.forename: Weiping
authors.initials: W
authors.lastname: Huang
authors.affiliation: Beijing Key Lab for Immune-Mediated Inflammatory Diseases, Institute of Clinical Medical Science, China-Japan Friendship Hospital, 2 East Yinghua Road, Chaoyang District, Beijing, 100029, China. lp8675@163.com.
authors.forename: Ping
authors.initials: P
authors.lastname: Li
mesh_terms: D000419:Albuminuria / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D015415:Biomarkers / Q000097:blood; D002681:China; D002985:Clinical Protocols; D003404:Creatinine / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000175:diagnosis; D003928:Diabetic Nephropathies / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000009:adverse effects / Q000627:therapeutic use*; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D007668:Kidney / Q000187:drug effects* / Q000503:physiopathology; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D004365:Drugs, Chinese Herbal; C000625138:tangshen; D003404:Creatinine
keywords: Chinese herbal medicine; Diabetic kidney disease; Macroalbuminuria; Randomized controlled trial; Tangshen Formula