Effects and Safety of Taurine Granule on Blood Pressure in Prehypertensive

Prehypertension Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816698
• Other study ID #: GZS01167262
• Status: Completed
• Phase: Phase 3
• First received: March 20, 2013
• Last updated: November 23, 2015
• Start date: December 2012
• Est. completion date: March 2015

Study information

• Verified date: November 2015
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Prehypertension

Intervention

Drug:
• Taurine granule
1 package(1.6g taurine granule) once a day after meals, 12 weeks
• Placebo
Placebo: 1 package once a day after meals, 12 weeks

Locations

Country	Name	City	State
China	The third hospital affiliated to the Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Zhiming Zhu

Country where clinical trial is conducted

China, 

Outcome

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