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NCT Number: NCT01816698

Effects and Safety of Taurine Granule on Blood Pressure in Prehypertensive

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.

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The third hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Taurine granule

Drug

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

Other names: Taurine granule, H20003861.

Placebo

Drug

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

Other names: Placebo packaged similar to Taurine granule

Primary outcomes

  1. The decrease in blood pressure after an 12-week oral Taurine granule administration.

    Time frame: 12 weeks

    Evaluate the effects of Taurine granule on blood pressure and metabolic parameters in prehypertensive patients after an 12-week oral administration.

Sponsors and collaborators

Lead sponsor

Zhiming Zhu

Other

Registry information

Official study title

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

Acronym: ESTAB

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 22, 2013
Registry last updated
Nov 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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