Songling Xuemaikang capsules for patients with low-to-medium risk hypertension: study protocol for a randomized controlled trial.

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.

SUBMITTER: Jiang Y 

PROVIDER: S-EPMC6466697 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature