Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
22 participants
INTERVENTIONAL
2007-05-31
2008-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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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).
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. Subjects who have signed an informed consent agreement.
3. Subjects with a history of nasal polyp symptoms during the previous 12 months.
Exclusion Criteria
2. Subjects presenting with unilateral polyps.
3. Subjects who have undergone surgery to treat their nasal polyps (nasal polypectomy) within one year prior to visit one.
4. Subjects who have a known fungal infection of the nose and/or paranasal sinuses, nasal candidiasis, acute or chronic infectious sinusitis of viral or bacterial nature.
5. Subjects who have had an upper respiratory tract infection within two weeks prior to Visit one or any time between Visit 1 and Visit 2.
6. Subjects having cystic fibrosis, Young's syndrome, primary ciliary dyskinesia, known HIV infection or alcohol abuse.
7. Subjects with clinically significant, uncontrolled evidence of cardiovascular, neurological, hepatic, renal, respiratory, or any other medical condition that may interfere with the study.
8. Subjects with a recent history (within six months) of a clinically significant psychiatric disorder other than mild depression.
9. Subjects who have any clinically relevant deviation from normal in the general physical examination.
10. Subjects who have received any depot, systemic or oral corticosteroid in the previous three months prior to the start of the study.
11. Subjects who are unable to cease treatment with intranasal steroids four weeks prior to Visit one.
12. Subjects with a known hypersensitivity to mint.
13. Females who are pregnant or lactating or are likely to become pregnant during the study or are less than 8 weeks postpartum. Women of childbearing age may be included if in the opinion of the investigator, they are taking adequate contraceptive measures.
14. Subjects who are unable to follow the instructions within this protocol or known inability to attend all clinic visits within the intervals stated.
15. Subjects who have participated in a clinical trial involving an investigational or marketed drug within four weeks of visit one.
16. Subjects who are allergy skin test positive to a seasonal allergen which will be present when performing the trial, that has caused, within the past 2 years, a clinically significant deterioration in nasal symptoms.
18 Years
ALL
Yes
Sponsors
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Hamilton Health Sciences Corporation
OTHER
Responsible Party
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Paul Keith
Associate Professor
Principal Investigators
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Paul K. Keith
Role: PRINCIPAL_INVESTIGATOR
Hamilton Health Sciences Corporation, McMaster Site
Countries
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References
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Finotto S, Dolovich J, Denburg JA, Jordana M, Marshall JS. Functional heterogeneity of mast cells isolated from different microenvironments within nasal polyp tissue. Clin Exp Immunol. 1994 Feb;95(2):343-50. doi: 10.1111/j.1365-2249.1994.tb06535.x.
McKay DL, Blumberg JB. A review of the bioactivity and potential health benefits of peppermint tea (Mentha piperita L.). Phytother Res. 2006 Aug;20(8):619-33. doi: 10.1002/ptr.1936.
Takano H, Osakabe N, Sanbongi C, Yanagisawa R, Inoue K, Yasuda A, Natsume M, Baba S, Ichiishi E, Yoshikawa T. Extract of Perilla frutescens enriched for rosmarinic acid, a polyphenolic phytochemical, inhibits seasonal allergic rhinoconjunctivitis in humans. Exp Biol Med (Maywood). 2004 Mar;229(3):247-54. doi: 10.1177/153537020422900305.
Ruhno J, Andersson B, Denburg J, Anderson M, Hitch D, Lapp P, Vanzieleghem M, Dolovich J. A double-blind comparison of intranasal budesonide with placebo for nasal polyposis. J Allergy Clin Immunol. 1990 Dec;86(6 Pt 1):946-53. doi: 10.1016/s0091-6749(05)80158-7.
Keith PK, Conway M, Dolovich J. Development and validation of a nasal polyposis quality of life questionnaire. J Allergy Clin Immunol 1996;97:192(Abstract)
Keith PK, Ferrie P, Conway M, Waserman S, Schmuck ML, Denburg JA. A double-blind, placebo-controlled, randomized, crossover trial of montelukast in adults with nasal polyposis. Allergy Clin Immunol Int: J World Allergy Org, 2003; Supp 1:185.(Abstract)
Powell KR, Shorr R, Cherry JD, Hendley JO. Improved method for collection of nasal mucus. J Infect Dis. 1977 Jul;136(1):109-11. doi: 10.1093/infdis/136.1.109.
Other Identifiers
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07-010
Identifier Type: -
Identifier Source: org_study_id