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

Last updated: March 7, 2020
Sponsor: Zhiming Zhu
Overall Status: Completed

Phase

2/3

Condition

Williams Syndrome

Circulation Disorders

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT01408446
GZS01167261
  • Ages 35-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Study Design

Total Participants: 36
Study Start date:
August 01, 2012
Estimated Completion Date:
August 30, 2013

Connect with a study center

  • The Third Military Medical University

    Chongqing, Chongqing 400042
    China

    Site Not Available

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