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

This study is currently recruiting participants.

Verified July 2011 by Third Military Medical University

Sponsor:

Information provided by:

Third Military Medical University

ClinicalTrials.gov Identifier:

NCT01408446

First received: July 25, 2011

Last updated: August 3, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

July 25, 2011

Last Updated Date

August 3, 2011

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The decrease in diastolic blood pressure after an 8-week oral menthol administration [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

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.

Original Primary Outcome Measures ^ICMJE

The decrease in diastolic blood pressure after an 8-week oral menthol administration [ Time Frame: 11weeks ] [ Designated as safety issue: Yes ]

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.

Change History

Complete list of historical versions of study NCT01408446 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Hypertension
Prehypertension

Intervention ^ICMJE

Drug: Menthol
Capsule 48mg three times a day after meals 8 weeks
Drug: Placebo
Capsule 48mg three times a day after meals 8 weeks

Study Arm (s)

Active Comparator: Menthol
Interventions Drug: Menthol Arms: Group 1

Intervention: Drug: Menthol
Placebo Comparator: Placebo
Interventions Drug: Placebo Arms: Group 2

Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2012

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

35 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Hongbo He, MD

86-023-68715705

cqhehongbo@gmail.com

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01408446

Other Study ID Numbers ^ICMJE

GZS01167261

Has Data Monitoring Committee

Yes

Responsible Party

Lin Zhou, The Third Military Medical University

Study Sponsor ^ICMJE

Third Military Medical University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Third Military Medical University

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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