Effects and Safety of Taurine Granule on Blood Pressure in Prehypertensive

Phase 3

Completed

• Conditions: Prehypertension
• Interventions: Drug: Taurine granule; Drug: Placebo

• Registration Number: NCT01816698
• Lead Sponsor: Zhiming Zhu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-20
• Study First Posted: 2013-03-22
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-23
• Last Update Posted: 2015-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Taurine	Taurine granule	Interventions Drug: Taurine granule Arms: Group 1
Placebo	Placebo	Interventions Drug: Placebo Arms: Group 2

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The third hospital affiliated to the Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China