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Effects and Safety of Taurine Granule on Blood Pressure in Prehypertensive

NCT ID: NCT01816698

Last Updated: 2015-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-03-31

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.

Detailed Description

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Conditions

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Prehypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Taurine

Interventions Drug: Taurine granule Arms: Group 1

Group Type ACTIVE_COMPARATOR

Taurine granule

Intervention Type DRUG

1 package(1.6g taurine granule) once a day after meals, 12 weeks

Placebo

Interventions Drug: Placebo Arms: Group 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo: 1 package once a day after meals, 12 weeks

Interventions

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Taurine granule

1 package(1.6g taurine granule) once a day after meals, 12 weeks

Intervention Type DRUG

Placebo

Placebo: 1 package once a day after meals, 12 weeks

Intervention Type DRUG

Other Intervention Names

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Taurine granule, H20003861. Placebo packaged similar to Taurine granule

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhiming Zhu

OTHER

Sponsor Role lead

Responsible Party

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Zhiming Zhu

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

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The third hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

Other Identifiers

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GZS01167262

Identifier Type: -

Identifier Source: org_study_id