search
Back to results

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

Primary Purpose

Prehypertension

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Taurine granule
Placebo
Sponsored by
Zhiming Zhu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prehypertension focused on measuring Hypertension, Taurine, Metabolism

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The third hospital affiliated to the Third Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Taurine

Placebo

Arm Description

Interventions Drug: Taurine granule Arms: Group 1

Interventions Drug: Placebo Arms: Group 2

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 20, 2013
Last Updated
November 23, 2015
Sponsor
Zhiming Zhu
search

1. Study Identification

Unique Protocol Identification Number
NCT01816698
Brief Title
Effects and Safety of Taurine Granule on Blood Pressure in Prehypertensive
Acronym
ESTAB
Official Title
A Randomized, Double-Blind, Placebo Control Trial Comparing Effects and Safety of TAURINE GRANULE and Placebo on Blood Pressure in Prehypertensive.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhiming Zhu

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prehypertension
Keywords
Hypertension, Taurine, Metabolism

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Taurine
Arm Type
Active Comparator
Arm Description
Interventions Drug: Taurine granule Arms: Group 1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Interventions Drug: Placebo Arms: Group 2
Intervention Type
Drug
Intervention Name(s)
Taurine granule
Other Intervention Name(s)
Taurine granule, H20003861.
Intervention Description
1 package(1.6g taurine granule) once a day after meals, 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo packaged similar to Taurine granule
Intervention Description
Placebo: 1 package once a day after meals, 12 weeks
Primary Outcome Measure Information:
Title
The decrease in blood pressure after an 12-week oral Taurine granule administration.
Description
Evaluate the effects of Taurine granule on blood pressure and metabolic parameters in prehypertensive patients after an 12-week oral administration.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
The third hospital affiliated to the Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China

12. IPD Sharing Statement

Learn more about this trial

Effects and Safety of Taurine Granule on Blood Pressure in Prehypertensive

We'll reach out to this number within 24 hrs