Effects and Safety of Taurine Granule on Blood Pressure in Prehypertensive (ESTAB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Third Military Medical University
Sponsor:
Information provided by (Responsible Party):
Zhiming Zhu, Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01816698
First received: March 20, 2013
Last updated: October 18, 2013
Last verified: October 2013

March 20, 2013
October 18, 2013
March 2013
January 2014   (final data collection date for primary outcome measure)
The decrease in blood pressure after an 12-week oral Taurine granule administration. [ Time Frame: JAN 2013 to JAN 2014 ] [ Designated as safety issue: Yes ]
Evaluate the effects of Taurine granule on blood pressure and metabolic parameters in prehypertensive patients after an 12-week oral administration.
Same as current
Complete list of historical versions of study NCT01816698 on ClinicalTrials.gov Archive Site
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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.

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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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Prehypertension
  • Drug: Taurine granule
    Taurine granule 0.8g once a day after meals, 12 weeks
    Other Name: Taurine granule, H20003861.
  • Drug: Placebo
    Placebo: 1 package once a day after meals, 12 weeks
    Other Name: Placebo packaged similar to Taurine granule
  • Active Comparator: Taurine
    Interventions Drug: Taurine granule Arms: Group 1
    Intervention: Drug: Taurine granule
  • Placebo Comparator: Placebo
    Interventions Drug: Placebo Arms: Group 2
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
25 Years to 75 Years
No
China
 
NCT01816698
GZS01167262
Yes
Zhiming Zhu, Third Military Medical University
Zhiming Zhu
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Third Military Medical University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP