Chinese Medical Journal (Jan 2017)

Efficacy and Safety of Niaoduqing Particles for Delaying Moderate-to-severe Renal Dysfunction: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study

  • Ying Zheng,
  • Guang-Yan Cai,
  • Li-Qun He,
  • Hong-Li Lin,
  • Xiao-Hong Cheng,
  • Nian-Song Wang,
  • Gui-Hua Jian,
  • Xu-Sheng Liu,
  • Yu-Ning Liu,
  • Zhao-Hui Ni,
  • Jing-Ai Fang,
  • Han-Lu Ding,
  • Wang Guo,
  • Ya-Ni He,
  • Li-Hua Wang,
  • Ya-Ping Wang,
  • Hong-Tao Yang,
  • Zhi-Ming Ye,
  • Ren-Huan Yu,
  • Li-Juan Zhao,
  • Wen-Hua Zhou,
  • Wen-Ge Li,
  • Hui-Juan Mao,
  • Yong-Li Zhan,
  • Zhao Hu,
  • Chen Yao,
  • Ri-Bao Wei,
  • Xiang-Mei Chen

DOI
https://doi.org/10.4103/0366-6999.216407
Journal volume & issue
Vol. 130, no. 20
pp. 2402 – 2409

Abstract

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Background: Chronic kidney disease (CKD) with moderate-to-severe renal dysfunction usually exhibits an irreversible course, and available treatments for delaying the progression to end-stage renal disease are limited. This study aimed to assess the efficacy and safety of the traditional Chinese medicine, Niaoduqing particles, for delaying renal dysfunction in patients with stage 3b-4 CKD. Methods: The present study was a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial. From May 2013 to December 2013, 300 CKD patients with an estimated glomerular filtration rate (eGFR) between 20 and 45 ml·min−1·1.73 m−2, aged 18–70 years were recruited from 22 hospitals in 11 Chinese provinces. Patients were randomized in a 1:1 ratio to either a test group, which was administered Niaoduqing particles 5 g thrice daily and 10 g before bedtime for 24 weeks, or a control group, which was administered a placebo using the same methods. The primary endpoints were changes in baseline serum creatinine (Scr) and eGFR after completion of treatment. The primary endpoints were analyzed using Student's t-test or Wilcoxon's rank-sum test. The present study reported results based on an intention-to-treat (ITT) analysis. Results: A total of 292 participants underwent the ITT analysis. At 24 weeks, the median (interquartile range) change in Scr was 1.1 (−13.0–24.1) and 11.7 (−2.6–42.9) μmol/L for the test and control groups, respectively (Z = 2.642, P = 0.008), and the median change in eGFR was −0.2 (−4.3–2.7) and −2.2 (−5.7–0.8) ml·min−1·1.73 m−2, respectively (Z = −2.408, P = 0.016). There were no significant differences in adverse events between the groups. Conclusions: Niaoduqing particles safely and effectively delayed CKD progression in patients with stage 3b-4 CKD. This traditional Chinese medicine may be a promising alternative medication for patients with moderate-to-severe renal dysfunction. Trial Registration: Chinese Clinical Trial Register, ChiCTR-TRC-12002448; http://www.chictr.org.cn/showproj.aspx?proj=7102.

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