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

Hypertension Clinical Trial

— ESMAB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408446
• Other study ID #: GZS01167261
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 1, 2012
• Est. completion date: August 30, 2013

Study information

• Verified date: March 2020
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: August 30, 2013
• Est. primary completion date: June 1, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Prehypertension

Intervention

Drug:
• Menthol
Capsule 48mg three times a day after meals 8 weeks
• Placebo
Capsule 48mg three times a day after meals 8 weeks

Locations

Country	Name	City	State
China	The Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Zhiming Zhu

Country where clinical trial is conducted

China, 

References & Publications (1)

Sun J, Yang T, Wang P, Ma S, Zhu Z, Pu Y, Li L, Zhao Y, Xiong S, Liu D, Zhu Z. Activation of cold-sensing transient receptor potential melastatin subtype 8 antagonizes vasoconstriction and hypertension through attenuating RhoA/Rho kinase pathway. Hyperten — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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