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

Phase 2

Completed

• Conditions: Prehypertension; Hypertension
• Interventions: Drug: Menthol; Drug: Placebo

• Registration Number: NCT01408446
• Lead Sponsor: Zhiming Zhu

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-08-02
• Study First Posted: 2011-08-03
• Study Start: 2012-08-01
• Primary Completion: 2013-06-01
• Study Completion: 2013-08-30
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-07
• Last Update Posted: 2020-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Menthol	Menthol	Interventions Drug: Menthol Arms: Group 1
Placebo	Placebo	Interventions Drug: Placebo Arms: Group 2

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

The Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China