Effects and Safety of Taurine Granule on Blood Pressure in Prehypertensive

Study Overview
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Brief Summary
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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.

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

Conditions
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Prehypertension

Intervention / Treatment
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* Drug: Taurine granule
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Blood pressure: 120mmHg≤SBP<140mmHg. Exclusion Criteria: Diabetes 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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Taurine<br>Interventions Drug: Taurine granule Arms: Group 1 | Drug: Taurine granule<br>* 1 package(1.6g taurine granule) once a day after meals, 12 weeks<br>* Other names: Taurine granule, H20003861.;|
| Placebo Comparator: Placebo<br>Interventions Drug: Placebo Arms: Group 2 | Drug: Placebo<br>* Placebo: 1 package once a day after meals, 12 weeks<br>* Other names: Placebo packaged similar to Taurine granule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decrease in blood pressure after an 12-week oral Taurine granule administration. | Evaluate the effects of Taurine granule on blood pressure and metabolic parameters in prehypertensive patients after an 12-week oral administration. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Taurine, Metabolism