Key result
Bushen Jiangya granules will be evaluated for their ability to reduce 24-hour average blood pressure compared to placebo in a planned trial of 260 patients with low-to-medium-risk hypertension.
Why the study?
Hypertension control rates remain low worldwide, and preliminary studies indicated that Bushen Jiangya granules could suppress ventricular hypertrophy, reduce inflammation, lower blood pressure, and protect target organs.
RCT (n=260)
Double-blind
1:1
No
Protocol tests BSJY for low-to-medium risk hypertension; RCT will confirm or refute preliminary effects before practice consideration.
INTRODUCTION: Hypertension is one of the most important risk factors for cardiovascular disease, and its control rates remain low worldwide. The most effective strategy is that patients with hypertension should be diagnosed and treated early. Preliminary studies showed that the Bushen Jiangya granule (BSJY) could suppress ventricular hypertrophy and inflammatory responses, lower blood pressure, and protect the target organs of hypertension. We designed a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of BSJY in patients with low-to-medium risk hypertension. METHODS AND ANALYSIS: This trial is a one-center, randomized, double-blind, placebo-controlled study. A total of 260 participants will be randomized in a 1:1 ratio to an experimental group (BSJY plus amlodipine) and a control group (placebo plus amlodipine). The trial cycle will last 8 weeks. The primary outcome is the change in 24-h average systolic and diastolic blood pressure. The secondary outcomes include heart rate variability, pharmacogenomic evaluation, improvement in TCM syndrome, and serum pro-inflammatory/anti-inflammatory cytokines between the two groups. The safety of medication will also be evaluated. All the data will be recorded in electronic case report forms and analyzed by SPSS V.22.0. ETHICS AND DISSEMINATION: This study has been approved by the Research Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences in Beijing, China (No. 2019-186-KY-01). The participants are volunteers, understand the process of this trial, and sign an informed consent. The results of this study will be disseminated to the public through peer-reviewed journals and academic conferences. DISCUSSION: We hypothesize that patients with low-to-medium-risk hypertension will benefit from BSJY. If successful, this study will provide evidence-based recommendations for clinicians. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiMCTR1900002876. Registered in November 2019.
No takes yet. Share an insight, caveat, or question.
Yang et al. (2022) conducted an RCT in Low-to-medium-risk hypertension (n=260). Bushen Jiangya granules (BSJY) plus amlodipine vs. Placebo plus amlodipine was evaluated on Change in 24-h average systolic and diastolic blood pressure. Bushen Jiangya granules will be evaluated for their ability to reduce 24-hour average blood pressure compared to placebo in a planned trial of 260 patients with low-to-medium-risk hypertension.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: