• Yuerong Jiang, Haiyan Guo, Yue Liu, Xin Wang, Jiaqi Liang, Ruixi Xi, Ruina Bai, and Dazhuo Shi.
• Cardiovascular Disease Center, Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, 100091, China. jiang_yuerong@163.com.
• Trials. 2019 Apr 15; 20 (1): 218.

BackgroundHypertension 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.Methods/DesignThis 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.DiscussionThis 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.Trial RegistrationChinese Clinical Trial Registry, ChiCTR-IPR-17011383 . Registered on 12 May 2017.

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