NCT01408446

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_2 hypertension

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 25, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 3, 2011

Completed
12 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2013

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

July 25, 2011

Last Update Submit

March 7, 2020

Conditions

HypertensionPrehypertension

Keywords

HypertensionMentholMetabolism

Outcome Measures

Primary Outcomes (1)

  • The decrease in diastolic blood pressure after an 8-week oral menthol administration

    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

Study Arms (2)

Menthol

ACTIVE COMPARATOR

Interventions Drug: Menthol Arms: Group 1

Drug: Menthol

Placebo

PLACEBO COMPARATOR

Interventions Drug: Placebo Arms: Group 2

Drug: Placebo

Interventions

MentholDRUG

Capsule 48mg three times a day after meals 8 weeks

Menthol
PlaceboDRUG

Capsule 48mg three times a day after meals 8 weeks

Placebo

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Related Publications (1)

  • Sun J, Yang T, Wang P, Ma S, Zhu Z, Pu Y, Li L, Zhao Y, Xiong S, Liu D, Zhu Z. Activation of cold-sensing transient receptor potential melastatin subtype 8 antagonizes vasoconstriction and hypertension through attenuating RhoA/Rho kinase pathway. Hypertension. 2014 Jun;63(6):1354-63. doi: 10.1161/HYPERTENSIONAHA.113.02573. Epub 2014 Mar 17.

    PMID: 24637663RESULT

Related Links

MeSH Terms

Conditions

HypertensionPrehypertension

Interventions

Menthol

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsCyclohexane MonoterpenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsMonoterpenesTerpenesLipids

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief Scientist of the National Key Basic Research and Development Program (973 Program)

Study Record Dates

First Submitted

July 25, 2011

First Posted

August 3, 2011

Study Start

August 1, 2012

Primary Completion

June 1, 2013

Study Completion

August 30, 2013

Last Updated

March 11, 2020

Record last verified: 2020-03

Locations

CN(1)