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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01408446
Recruitment Status : Completed
First Posted : August 3, 2011
Last Update Posted : March 11, 2020
Sponsor:
Information provided by (Responsible Party):
Zhiming Zhu, Third Military Medical University

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

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Study Type : Interventional  (Clinical Trial)
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 : August 1, 2012
Actual Primary Completion Date : June 1, 2013
Actual Study Completion Date : August 30, 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Menthol

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




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01408446


Locations
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China, Chongqing
The Third Military Medical University
Chongqing, Chongqing, China, 400042
Sponsors and Collaborators
Zhiming Zhu
Additional Information:
Publications of Results:
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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: August 3, 2011    Key Record Dates
Last Update Posted: March 11, 2020
Last Verified: March 2020
Keywords provided by Zhiming Zhu, Third Military Medical University:
Hypertension
Menthol
Metabolism
Additional relevant MeSH terms:
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Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases
Menthol
Antipruritics
Dermatologic Agents