Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Hypertension | Study protocol

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

Authors: Yuerong Jiang, Haiyan Guo, Yue Liu, Xin Wang, Jiaqi Liang, Ruixi Xi, Ruina Bai, Dazhuo Shi

Published in: Trials | Issue 1/2019

Login to get access

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.
Appendix
Available only for authorised users
Literature
1.
He J. Hypertension in China: a large and increasing public health challenge. J Hypertens. 2016;34(1):29–31.CrossRef
2.
Wang Y, Wang QJ. The prevalence of prehypertension and hypertension among US adults according to the new joint national committee guidelines: new challenges of the old problem. Arch Intern Med. 2004;164:2126–34.CrossRef
3.
Choi KM, Park HS, Han JH, Lee JS, Lee J, Ryu OH, et al. Prevalence of prehypertension and hypertension in a Korean population: Korean National Health and Nutrition Survey 2001. J Hypertens. 2006;24:1515–21.CrossRef
4.
InterASIA Collaborative Group. Cardiovascular risk factor levels in urban and rural Thailand-The International Collaborative Study of Cardiovascular Disease in Asia (InterASIA). Eur J Cardiovasc Prev Rehabil. 2003;10:249–57.CrossRef
5.
Wolf-Maier K, Cooper RS, Kramer H, Banegas JR, Giampaoli S, Joffres MR, et al. Hypertension treatment and control in five European countries, Canada, and United States. Hypertension. 2004;43:10–7.CrossRef
6.
Turner AJ, Hooper NM. The angiotensin-converting enzyme gene family: genomics and pharmacology. Trends Pharmacol Sci. 2002;23:177–83.CrossRef
7.
Li W, Gu H, Teo KK, Bo J, Wang Y, Yang J, et al. Hypertension prevalence, awareness, treatment, and control in 115 rural and urban communities involving 47 000 people from China. J Hypertens. 2016;34(1):39–46.CrossRef
8.
Guo YD, Xing ZL, Shu BR, Liu CL, Jia ZL. Effects of puerarin combined with telmisartan on adipocytokines, activity of renin angiotensin system and insulin resistance in patients with obesity-related hypertension. Hebei Med J. 2016;13:1970–3.
9.
Ni XQ, Li X, Zhao LH, Liu SW, Ma J, Xu JH. Effect of puerarin on cardiac cholinergic innervation ischemic area in rats after myocardial infarction. Chin J New Drugs Clin Remedies. 2005;24(12):968–70.
10.
Gao L, Ji X, Song J, Liu P, Yan F, Gong W, et al. Puerarin protects against ischemic brain injury in a rat model of transient focal ischemia. Neurol Res. 2009;31(4):402–6.CrossRef
11.
Pan ZY, Bao ZS, Wu ZM, Wang XM, Zheng JZ, Shen YL, et al. The myocardial protective effects of puerarin on STZ-induced diabetic rats. Fen Zi Xi Bao Sheng Wu Xue Bao. 2009;42(2):137–44.PubMed
12.
Tiwari AK, Srinivas PV, Kumar SP, Rao JM. Free radical scavenging active components from Cedrus deodara. J Agric Food Chem. 2001;49:4642–5.CrossRef
13.
Chen XY. Study on antioxidant properties of pine needles of Masson Pine[in Chinese]. Hubei Agric Sci. 2003;(1):78–80.
14.
Yang XC, Xiong XJ, Yang GY, Wang HR, Wang J. Songling Xuemaikang Capsule for primary hypertension: A systematic review of randomized controlled trials. Chin J Integr Med. 2015;21(4):312–20.CrossRef
15.
Dong ZY, Gao Y, Wu SX, Xu L. Effects of different antihypertensive regimens combined with Song ling xue mai kang capsule on antihypertensive effect. Chin J Integr Med Cardio Cerebrovasc Dis. 2013;9(11):1055–6.
16.
Lan HB, Yuan HP. Clinical research of Songling Xuemai Kang combined with maleic acid enalaprilat folic acid pill in treatment of essential hypertension of kidney and liver yin deficiency. Clin J Chin Med. 2015;7(21):37–9.
17.
Campbell MK, Piaggio G, Elbourne DR, Altman DG, CONSORT Group. CONSORT 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661.CrossRef
18.
James PA, Oparil S, Carter BL, Cushman WC, Dennison-Himmelfarb C, Handler J, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507–20.CrossRef
19.
Jialin C. Ambulatory blood pressure monitoring for the hypotensive effect of Songling Xuemaikang Capsule. Sichuan Med J. 2002;23(11):1149–50.
20.
Lee JS, Kim HG, Lee HW, Kim WY, Ahn Y, Son CG. Pine needle extract prevents hippocampal memory impairment in acute restraint stress mouse model. J Ethnopharmacol. 2017;207:226–36.CrossRef
21.
Tan C, Wang A, Liu C, Li Y, Shi Y, Zhou MS. Puerarin improves vascular insulin resistance and cardiovascular remodeling in salt-sensitive hypertension. Am J Chin Med. 2017;45(6):1169–84.CrossRef
22.
Jin G, Yang P, Gong Y, Fan X, Tang J, Lin J. Effects of puerarin on expression of apelin and its receptor of 2K1C renal hypertension rats [in Chinese]. Zhongguo Zhong Yao Za Zhi. 2009;34(24):3263–7.PubMed
23.
Dai J, Duan JA, Li YB, Liu R, Peng YR. Investigation of sedative bioactive components and evaluation of the biological effect of freshwater pearls produced in Suzhou [in Chinese]. Chin J Biochem Pharmaceutics. 2008;29(5):294–8.
24.
Xiao MF, Zhou D. Effects of “Huoxue Qianyang Granule” on rennin-angiotensin system in plasma of spontaneous hypertensive rats. Shanghai J Tradit Chin Med. 2007;41:59–61.
25.
Wan LH, Xiong WB, Zhu L, Liu R, Xie F, Liu JQ, et al. The antihypertensive effect and mechanism of Songling Xuemaikang Capsule on spontaneously hypertensive rats[in Chinese]. Sichuan J Physiol Sci. 2005;27(3):133–4.
Metadata
Title
Songling Xuemaikang capsules for patients with low-to-medium risk hypertension: study protocol for a randomized controlled trial
Authors
Yuerong Jiang
Haiyan Guo
Yue Liu
Xin Wang
Jiaqi Liang
Ruixi Xi
Ruina Bai
Dazhuo Shi
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3308-5

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue

Study protocol

The Oxford study of Calcium channel Antagonism, Cognition, Mood instability and Sleep (OxCaMS): study protocol for a randomised controlled, experimental medicine study

Study protocol

Effect of electro-acupuncture on lateralization of the human swallowing motor cortex excitability in healthy subjects: study protocol for a single-blind, randomized controlled trial

Study protocol

Prospective randomized controlled trial comparing the efficacy and safety of Roux-en-Y gastric bypass and one-anastomosis gastric bypass (the RYSA trial): trial protocol and interim analysis

Study protocol

Effect of lacosamide in peripheral neuropathic pain: study protocol for a randomized, placebo-controlled, phenotype-stratified trial

Study protocol

COSUTI: a protocol for the development of a core outcome set (COS) for interventions for the treatment of uncomplicated urinary tract infection (UTI) in adults

Methodology

Beyond interviews and focus groups: a framework for integrating innovative qualitative methods into randomised controlled trials of complex public health interventions