1. Songling Xuemaikang capsules for patients with low-to-medium risk hypertension: study protocol for a randomized controlled trial
- Author
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Jiaqi Liang, Yue-rong Jiang, Rui-Na Bai, Hai-Yan Guo, Dazhuo Shi, Yue Liu, Ruixi Xi, and Xin Wang
- Subjects
Adult ,medicine.medical_specialty ,Medicine (miscellaneous) ,Capsules ,Traditional Chinese medicine ,Disease ,Placebo ,law.invention ,Study Protocol ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Randomized controlled trial ,law ,Multicenter trial ,Internal medicine ,Outcome Assessment, Health Care ,medicine ,Humans ,Pharmacology (medical) ,030212 general & internal medicine ,Medicine, Chinese Traditional ,Risk factor ,Aged ,Randomized Controlled Trials as Topic ,lcsh:R5-920 ,business.industry ,Middle Aged ,Clinical trial ,Blood pressure ,Sample Size ,Hypertension ,Low-to-medium risk ,business ,lcsh:Medicine (General) ,030217 neurology & neurosurgery ,Drugs, Chinese Herbal ,Songling Xuemaikang capsule - Abstract
Background 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. Methods/design 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. Discussion 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. Trial registration Chinese Clinical Trial Registry, ChiCTR-IPR-17011383. Registered on 12 May 2017. Electronic supplementary material The online version of this article (10.1186/s13063-019-3308-5) contains supplementary material, which is available to authorized users.
- Published
- 2019