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  • 标题:Songling Xuemaikang capsules for patients with low-to-medium risk hypertension: study protocol for a randomized controlled trial
  • 本地全文:下载
  • 作者:Yuerong Jiang ; Haiyan Guo ; Yue Liu
  • 期刊名称:Trials
  • 印刷版ISSN:1745-6215
  • 电子版ISSN:1745-6215
  • 出版年度:2019
  • 卷号:20
  • 期号:1
  • 页码:218-224
  • DOI:10.1186/s13063-019-3308-5
  • 出版社:BioMed Central
  • 摘要:Hypertension is a major risk factor for cardio-cerebrovascular disease. Songling Xuemaikang capsules (SXC), a formulation of Chinese herbal patent medicine, has been used as a complementary medicine with conventional western medicine to treat patients with hypertension since 1994 in mainland China. However, the efficacy of treatment with SXC alone against hypertension remains unclear. This is a multicenter, placebo-controlled, double-blinded, randomized controlled clinical trial. A total of 570 patients with low-to-medium risk hypertension are randomized in a 1:1 ratio to receive SXC or placebo three times daily for eight weeks. The primary outcomes are 24-h average systolic blood pressure and average diastolic blood pressure. The secondary outcomes are daytime average blood pressure, night-time average blood pressure, fluctuation of blood pressure, hypertension control rate, traditional Chinese medicine (TCM) syndrome scores, and quality-of-life scores. This is the first multicenter trial conducted to evaluate the efficacy and safety of TCM in patients with low-to-medium risk hypertension. Our study will provide evidence-based results of a complementary preventive measure for hypertension. Chinese Clinical Trial Registry, ChiCTR-IPR-17011383 . Registered on 12 May 2017.
  • 关键词:Hypertension; Low-to-medium risk; Songling Xuemaikang capsule; Randomized controlled trial
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