Effects and Safety of Menthol on Blood Pressure and Metabolic Parameters in Prehypertensive and Mild Hypertensive Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-01

Study Completion Date

2013-08-30

Brief Summary

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Prehypertension and mild hypertension 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. Peppermint is a popular flavoring agent, and peppermint tea help relax tension and could lower blood pressure. The effect of oral peppermint on blood pressure is not consistent, however, our previous animal study has shown that oral administration of menthol, the main component of peppermint, could reduce 24-hour mean arterial systolic and diastolic blood pressure in spontaneous hypertensive rats. Furthermore, menthol increases uncoupling protein(UCP)1 dependent thermogenesis and energy expenditure through transient receptor potential melastatin(TRPM)8 activation, and helps prevent obesity and metabolic disorders. In a prospective, double-blind, randomized, and parallel-group study, we will evaluate the effects of DANSHU capsule(menthol) 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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Detailed Description

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Conditions

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Hypertension Prehypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Menthol

Interventions Drug: Menthol Arms: Group 1

Group Type ACTIVE_COMPARATOR

Menthol

Intervention Type DRUG

Capsule 48mg three times a day after meals 8 weeks

Placebo

Interventions Drug: Placebo Arms: Group 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsule 48mg three times a day after meals 8 weeks

Interventions

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Menthol

Capsule 48mg three times a day after meals 8 weeks

Intervention Type DRUG

Placebo

Capsule 48mg three times a day after meals 8 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Blood pressure: 120mmHg≤SBP\<160mmHg, and/or 80mmHg≤DBP\<100mmHg

Exclusion Criteria

* Diabetes
* Hypertension: SBP≥160mmHg, or DBP≥100mmHg
* 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

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes