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

This study is currently recruiting participants.
Verified October 2013 by Third Military Medical University
Sponsor:
Information provided by (Responsible Party):
Zhiming Zhu, Third Military Medical University
ClinicalTrials.gov Identifier:
NCT01408446
First received: July 25, 2011
Last updated: October 27, 2013
Last verified: October 2013

July 25, 2011
October 27, 2013
August 2012
October 2013   (final data collection date for primary outcome measure)
The decrease in diastolic blood pressure after an 8-week oral menthol administration [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
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.
The decrease in diastolic blood pressure after an 8-week oral menthol administration [ Time Frame: 11weeks ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT01408446 on ClinicalTrials.gov Archive Site
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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

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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Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Hypertension
  • Prehypertension
  • Drug: Menthol
    Capsule 48mg three times a day after meals 8 weeks
  • Drug: Placebo
    Capsule 48mg three times a day after meals 8 weeks
  • Active Comparator: Menthol
    Interventions Drug: Menthol Arms: Group 1
    Intervention: Drug: Menthol
  • Placebo Comparator: Placebo
    Interventions Drug: Placebo Arms: Group 2
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
April 2014
October 2013   (final data collection date for primary outcome measure)

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
Both
35 Years to 65 Years
Yes
Contact: Hongbo He, MD 86-023-68715705 cqhehongbo@gmail.com
China
 
NCT01408446
GZS01167261
Yes
Zhiming Zhu, Third Military Medical University
Zhiming Zhu
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Not Provided
Third Military Medical University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP