Clinical Trial: Mint Tea for the Treatment of Nasal Polyps

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double-blind,Placebo-controlled, Randomized, Crossover Trial of Mint Tea High in Rosmarinic Acid in Adults With Nasal Polyposis

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of a new treatment for nasal polyps as compared to placebo (an inactive substance). The treatment involved is mint tea high in rosmarinic acid. Rosmarinic acid is a polyphenol, or a chemical substance found in certain plants such as oregano, rosemary, and the mints. It is the active ingredient in spearmint. The placebo used in this study will be mint tea low in rosmarininc acid. In this trial the amount of rosmarinic acid in the high rosmarinic acid tea, or study tea, will be 150mg. The placebo, or low rosmarinic acid tea, will contain 10mg of rosmarinic acid.

Detailed Summary:

Nasal polyps are clear, glistening, grape-like structures that occur in two percent of adults and contain a large number of activated eosinophils - about 20% of the constituents of nasal polyp tissue.

The standard treatment for nasal polyp patients is intranasal steroids which, in troublesome cases, may follow a short course of oral steroids. Surgery is reserved for extremely large polyps and those who fail medical treatment. However, many patients tire of using nasal sprays or are troubled by side effects such as nasal irritation or bleeding. So, while all treatments offer some benefit, there is no gold standard.

Rosmarinic acid is categorized as a polyphenolia phytochemical, or a 'plant phenol' and is found in a variety of plants including the herbs oregano and rosemary, as well as the mints. Peppermint is one of the most widely used single ingredient in herbal teas. It has been found in vitro to have significant antimicrobial and antiviral properties, strong antioxidant and antitumor actions, and some antiallergenic ability. Human based research is limited.

A mint tea high in rosmarinic acid has recently been produced. Anecdotal evidence suggests that it may be beneficial for allergic rhinitis if taken prior to allergen exposure (personal communication). Other anecdotal evidence found a blunting of the sputum eosinophils following allergen challenge in allergic asthmatics (personal communication). This trial aims to study the effects of this mint tea high in rosmarinic acid in adults with bilateral nasal polyps, a condition characterized by chronic eosinophilic inflammation. The control treatment will be a mint tea low in rosmarinic acid.


Sponsor: Hamilton Health Sciences Corporation

Current Primary Outcome:

  • Nasal polyposis quality of life questionnaire [ Time Frame: Visits 2, 3,4,5 ]
  • Nasal patency as assessed by use of the Clement-Clarke peak nasal inspiratory flow meter (PNIF) [ Time Frame: Daily ]


Original Primary Outcome:

  • Subject's Quality of Life assessment will be made at baseline (prior to randomization), after 4 weeks of treatment, after 4 weeks of washout, and
  • Nasal patency will be measured with a peak nasal inspiratory flow meter (PNIF). Study participants will measure their PNIF twice a day and will record their results on a diary throughout the study.


Current Secondary Outcome:

  • Nasal lavage eosinophils. [ Time Frame: Visits 1,2,3,4,5 ]
  • Peripheral blood eosinophils [ Time Frame: Visits 2,3,4,5 ]
  • Diary symptom scores. [ Time Frame: Daily ]
  • Nasal polyp size on visual inspection. [ Time Frame: Visits 1,2,3,4,5 ]
  • Subjects Global Assessment of symptoms [ Time Frame: Visits 3 and 5 ]


Original Secondary Outcome:

  • Nasal eosinophils will be collected at screening, baseline, after 4 weeks of treatment, after 4 weeks of washout, and after 4 weeks of crossover treatment.
  • Peripheral blood eosinophils will be collected at baseline,after 4 weeks of treatment, after 4 weeks of washout, and again after 4 weeks of crossover treatment.
  • Diary symptom scores will be recorded twice daily by the subject.
  • Nasal polyp size on visual inspection will be assessed by study physician at screening, baseline, after 4 weeks of treatment, after 4 weeks of wash-out, and again after 4 weeks of crossover treatment.
  • Subjects will complete their Global Assessment of symptoms, describing their perception of the change in their nasal polyp symptoms over the course of the study. This assessment will be completed at the end of each treatment period.


Information By: McMaster University

Dates:
Date Received: April 23, 2007
Date Started: May 2007
Date Completion:
Last Updated: December 8, 2011
Last Verified: December 2011