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OpenTrials
Completed

NCT Number: NCT01408446

Effects and Safety of Menthol 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.

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Menthol

Drug

Capsule 48mg three times a day after meals 8 weeks

Placebo

Drug

Capsule 48mg three times a day after meals 8 weeks

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Zhiming Zhu

Other

Registry information

Official study title

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

Acronym: ESMAB

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 3, 2011
Registry last updated
Mar 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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