Effects and Safety of Taurine Granule on Blood Pressure in Prehypertensive

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01816698

Acronym

ESTAB

Enrollment

120

Registered

2013-03-22

Start date

2012-12-31

Completion date

2015-03-31

Last updated

2015-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prehypertension

Keywords

Hypertension, Taurine, Metabolism

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.

Interventions

DRUGTaurine granule

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026