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临床试验/NCT01816698
NCT01816698已完成3 期

A Randomized, Double-Blind, Placebo Control Trial Comparing Effects and Safety of TAURINE GRANULE and Placebo on Blood Pressure in Prehypertensive.

Zhiming Zhu1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
The decrease in blood pressure after an 12-week oral Taurine granule administration.

研究概览

简要总结

Prehypertension are associated with an increased risk of atherosclerosis and coronary artery disease, and often complicated with the metabolic disorder of glucose and lipid. The comprehensive prevention of hypertension is still an important and complex clinical issue. Taurine is one of the ingredients of Chinese medicine bezoar ,as an endogenous amino acids is central inhibitory neurotransmitter, can regulate the excitability of nerve tissue, regulate body temperature, therefore, antipyretic, sedative, analgesic, anti-inflammatory,the role of anti-rheumatic, anti-convulsant. In addition, Taurine inhibits platelet aggregation in the circulatory system, lower blood lipids, to maintain the body's normal blood pressure and prevent atherosclerosis; protective effect on myocardial cells, can be anti-arrhythmic; special efficacy to lower blood cholesterol, to treat heart failure. The effect of oral Taurine on blood pressure is not consistent, however, many animal study has shown that oral administration of Taurine, could reduce 24-hour mean arterial systolic and diastolic blood pressure in spontaneous hypertensive rats. Furthermore, Taurine interfere with calcium and low affinity binding of the calcium binding sites, decrease the voltage-dependent Ca2+channel in vascular smooth muscle relaxation, vasodilation, lower blood pressure.In a prospective, double-blind, randomized, and parallel-group study, we will evaluate the effects of Taurine granule on blood pressure and metabolic parameters in prehypertensive and mild hypertensive patients. This study will help develop future comprehensive prevention and treatment strategies for hypertension.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Blood pressure: 120mmHg≤SBP<140mmHg.

排除标准

  • Hypertension: SBP≥140mmHg, or DBP≥90mmHg.
  • known allergy to trial drugs
  • Myocardial infarction or cerebrovascular accident in the year preceding the trial
  • Clinical Congestive Heart Failure
  • Secondary hypertension
  • Pregnancy or lactating women
  • Malignant tumor
  • Gastroesophageal reflux or gastroduodenal ulcer
  • History of hepatitis or cirrhosis
  • History of kidney disease
  • Body weight﹤35Kg

研究组 & 干预措施

Taurine

Active Comparator

Interventions Drug: Taurine granule Arms: Group 1

干预措施: Taurine granule (Drug)

Placebo

Placebo Comparator

Interventions Drug: Placebo Arms: Group 2

干预措施: Placebo (Drug)

结局指标

主要结局

The decrease in blood pressure after an 12-week oral Taurine granule administration.

时间窗: 12 weeks

Evaluate the effects of Taurine granule on blood pressure and metabolic parameters in prehypertensive patients after an 12-week oral administration.

次要结局

未报告次要终点

研究者

发起方
Zhiming Zhu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhiming Zhu

Chief Scientist of the National Key Basic Research and Development Program (973 Program)

Third Military Medical University

研究点 (1)

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