Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465543
Status:
COMPLETED
Last Update Posted:
2011-12-09
First Post:
2007-04-23
Brief Title:
Mint Tea for the Treatment of Nasal Polyps
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
Official Title:
A Double-blindPlacebo-controlled Randomized Crossover Trial of Mint Tea High in Rosmarinic Acid in Adults With Nasal Polyposis
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None