A Randomized, Double-Blind, Placebo Control Trial Comparing Effects and Safety of TAURINE GRANULE and Placebo on Blood Pressure in Prehypertensive.
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
- 否
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
Interventions Drug: Taurine granule Arms: Group 1
干预措施: Taurine granule (Drug)
Placebo
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
Zhiming Zhu
Chief Scientist of the National Key Basic Research and Development Program (973 Program)
Third Military Medical University
