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CompletedNCT01816698ESTABUpdated Nov 24, 2015

Effects and Safety of Taurine Granule on Blood Pressure in Prehypertensive

A Phase 3 interventional study of Taurine granule and Placebo in Prehypertension, sponsored by Zhiming Zhu. Completed at 1 site in China. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-11-24.

Sponsored by Zhiming Zhu · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
25 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Prehypertension

Keywords

  • Hypertension
  • Taurine
  • Metabolism
03

In context

Prehypertension

151 studies on the registry are indexed under Prehypertension; 22 are open to participants now.

This study's enrollment of 120 is above the median of 64 across 133 interventional studies indexed under Prehypertension.

Browse Prehypertension studies →

Lead sponsor

Zhiming Zhu is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Blood pressure: 120mmHg≤SBP\<140mmHg.

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (actual)

Study arms

  • Active comparator
    Taurine

    Interventions Drug: Taurine granule Arms: Group 1

    Drug: Taurine granule

  • Placebo comparator
    Placebo

    Interventions Drug: Placebo Arms: Group 2

    Drug: Placebo

Interventions

  • DrugTaurine granule

    1 package(1.6g taurine granule) once a day after meals, 12 weeks

    Also known as: Taurine granule, H20003861.

  • DrugPlacebo

    Placebo: 1 package once a day after meals, 12 weeks

    Also known as: Placebo packaged similar to Taurine granule

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

07

Study locations

1 site
  • The third hospital affiliated to the Third Military Medical University
    Chongqing, Chongqing Municipality 400042, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01816698
Lead sponsor
Zhiming Zhu
Responsible party
Zhiming Zhu (Chief Scientist of the National Key Basic Research and Development Program (973 Program), Third Military Medical University) — Sponsor-investigator
First posted
Mar 22, 2013
Start date
Dec 2012
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Nov 24, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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