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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01816698
Recruitment Status : Completed
First Posted : March 22, 2013
Last Update Posted : November 24, 2015
Information provided by (Responsible Party):
Zhiming Zhu, Third Military Medical University

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.

Condition or disease Intervention/treatment Phase
Prehypertension Drug: Taurine granule Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Double-Blind, Placebo Control Trial Comparing Effects and Safety of TAURINE GRANULE and Placebo on Blood Pressure in Prehypertensive.
Study Start Date : December 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Taurine

Arm Intervention/treatment
Active Comparator: Taurine
Interventions Drug: Taurine granule Arms: Group 1
Drug: Taurine granule
1 package(1.6g taurine granule) once a day after meals, 12 weeks
Other Name: Taurine granule, H20003861.

Placebo Comparator: Placebo
Interventions Drug: Placebo Arms: Group 2
Drug: Placebo
Placebo: 1 package once a day after meals, 12 weeks
Other Name: Placebo packaged similar to Taurine granule

Primary Outcome Measures :
  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.

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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01816698

China, Chongqing
The third hospital affiliated to the Third Military Medical University
Chongqing, Chongqing, China, 400042
Sponsors and Collaborators
Zhiming Zhu

Responsible Party: Zhiming Zhu, Chief Scientist of the National Key Basic Research and Development Program (973 Program), Third Military Medical University Identifier: NCT01816698     History of Changes
Other Study ID Numbers: GZS01167262
First Posted: March 22, 2013    Key Record Dates
Last Update Posted: November 24, 2015
Last Verified: November 2015

Keywords provided by Zhiming Zhu, Third Military Medical University:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases