Clinical trial NCT01816698: Effects and Safety of Taurine Granule on Blood Pressure in Prehypertensive
Official title: A Randomized, Double-Blind, Placebo Control Trial Comparing Effects and Safety of TAURINE GRANULE and Placebo on Blood Pressure in Prehypertensive.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prehypertension
Keywords: Hypertension
Taurine
Metabolism
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: The decrease in blood pressure after an 12-week oral Taurine granule administration.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The third hospital affiliated to the Third Military Medical University
state: Chongqing
Study officials:
References: