Mint Tea for the Treatment of Nasal Polyps
|Nasal Polyps||Other: Mint tea high in rosmarinic acid Other: Mint tea low in rosmarinic acid||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||A Double-blind,Placebo-controlled, Randomized, Crossover Trial of Mint Tea High in Rosmarinic Acid in Adults With Nasal Polyposis|
- 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 ]
- 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 ]
|Study Start Date:||May 2007|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Placebo Comparator: II
Arm 2 receives 4 weeks of placebo mint tea (consumed twice a day) followed by 4 weeks of washout and then a further 4 weeks of treatment with study mint tea (consumed twice a day).
Other: Mint tea low in rosmarinic acid
Mint tea low in rosmarininc acid contains 10mg of rosmarinic acid. To be consumed twice a day for 4 weeks. Brewed in 150ml of boiling water and allowed to steep for 10 minutes.
Placebo Comparator: I
Arm 1 receives 4 weeks of treatment with mint tea high in rosmarinic acid, consumed twice a day. Treatment is followed by a 4 week wash-out phase. Subjects then enter a 4 week phase of placebo mint tea (low in rosmarinic acid), to be consumed twice a day.
Other: Mint tea high in rosmarinic acid
Mint tea high in rosmarininc acid contains 150mg of rosmarinic acid. To be consumed twice a day for 4 weeks. Brewed in 150ml of boiling water and allowed to steep for 10 minutes.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465543
|Principal Investigator:||Paul K. Keith||Hamilton Health Sciences Corporation, McMaster Site|