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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hypertension, Prehypertension

Intervention / Treatment
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* Drug: Menthol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Menthol<br>Interventions Drug: Menthol Arms: Group 1 | Drug: Menthol<br>* Capsule 48mg three times a day after meals 8 weeks<br>|
| Placebo Comparator: Placebo<br>Interventions Drug: Placebo Arms: Group 2 | Drug: Placebo<br>* Capsule 48mg three times a day after meals 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The decrease in diastolic blood pressure after an 8-week oral menthol administration | 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. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Menthol, Metabolism