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

Sponsor

Zhiming Zhu (Other)

Overall Status

Completed

CT.gov ID

NCT01408446

Collaborator

(none)

Enrollment

Location

Arms

12.9

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Prehypertension	Drug: Menthol Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official 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

Actual Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Aug 30, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Third Military Medical University	Chongqing	Chongqing	China	400042

Sponsors and Collaborators

Zhiming Zhu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Related Info

Publications

None provided.

Responsible Party:

Zhiming Zhu, Chief Scientist of the National Key Basic Research and Development Program (973 Program), Third Military Medical University

ClinicalTrials.gov Identifier:

NCT01408446

Other Study ID Numbers:

GZS01167261

First Posted:

Aug 3, 2011

Last Update Posted:

Mar 11, 2020

Last Verified:

Mar 1, 2020

Keywords provided by Zhiming Zhu, Chief Scientist of the National Key Basic Research and Development Program (973 Program), Third Military Medical University

Hypertension

Menthol

Metabolism

Additional relevant MeSH terms:

Hypertension

Prehypertension

Menthol

Study Results

No Results Posted as of Mar 11, 2020