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

March 7, 2020 updated by: Zhiming Zhu

A Randomized, Double-Blind, Placebo Control Trial Comparing Effects and Safety of DANSHU Capsule(Menthol) and Placebo on Blood Pressure and Metabolic Parameters in Prehypertensive and Mild Hypertensive Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • The Third Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Menthol
Interventions Drug: Menthol Arms: Group 1
Drug: Menthol
Capsule 48mg three times a day after meals 8 weeks
Placebo Comparator: Placebo
Interventions Drug: Placebo Arms: Group 2
Drug: Placebo
Capsule 48mg three times a day after meals 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The decrease in diastolic blood pressure after an 8-week oral menthol administration
Time Frame: 8 weeks
Evaluate the effects of DANSHU capsule(menthol) on blood pressure and metabolic parameters in prehypertensive and mild hypertensive patients after an 8-week oral administration.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhiming Zhu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

August 30, 2013

Study Registration Dates

First Submitted

July 25, 2011

First Submitted That Met QC Criteria

August 2, 2011

First Posted (Estimate)

August 3, 2011

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 7, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GZS01167261

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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