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
  Purpose

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 Intervention Phase
Prehypertension
Drug: Taurine granule
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Third Military Medical University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: March 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Taurine
Interventions Drug: Taurine granule Arms: Group 1
Drug: Taurine granule
Taurine granule 0.8g 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

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01816698

Locations
China, Chongqing
The third hospital affiliated to the Third Military Medical University Recruiting
Chongqing, Chongqing, China, 400042
Contact: Hongbo He, M.D.       cqhehongbo@gmail.com   
Principal Investigator: Zhiming Zhu, MD., PhD.         
Sponsors and Collaborators
Zhiming Zhu
  More Information

No publications provided

Responsible Party: Zhiming Zhu, Chief Scientist of the National Key Basic Research and Development Program (973 Program), Third Military Medical University
ClinicalTrials.gov Identifier: NCT01816698     History of Changes
Other Study ID Numbers: GZS01167262
Study First Received: March 20, 2013
Last Updated: October 18, 2013
Health Authority: China: Ministry of Health

Keywords provided by Third Military Medical University:
Hypertension
Taurine
Metabolism

Additional relevant MeSH terms:
Prehypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014