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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01408446

Acronym

ESMAB

Enrollment

Registered

2011-08-03

Start date

2012-08-01

Completion date

2013-08-30

Last updated

2020-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Prehypertension

Keywords

Hypertension, Menthol, Metabolism

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.

Interventions

DRUGMenthol

Capsule 48mg three times a day after meals 8 weeks

DRUGPlacebo

Capsule 48mg three times a day after meals 8 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

35 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
The decrease in diastolic blood pressure after an 8-week oral menthol administration	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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026