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Sponsored by: |
Hamilton Health Sciences |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00465543 |
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.
Condition | Intervention | Phase |
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Nasal Polyps |
Other: Mint tea high in rosmarinic acid Other: Mint tea low in rosmarinic acid |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind,Placebo-Controlled, Randomized, Crossover Trial of Mint Tea High in Rosmarinic Acid in Adults With Nasal Polyposis |
Enrollment: | 22 |
Study Start Date: | May 2007 |
Study Completion Date: | June 2008 |
Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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II: Placebo Comparator
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).
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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.
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I: Placebo Comparator
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.
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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.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Hamilton Health Sciences Corporation, McMaster Site | |
Hamilton,, Ontario, Canada, L8N 3Z5 |
Principal Investigator: | Paul K. Keith | Hamilton Health Sciences Corporation, McMaster Site |
Responsible Party: | Hamilton Health Sciences ( Dr/ Paul Keith Associate Professor ) |
Study ID Numbers: | 07-010 |
Study First Received: | April 23, 2007 |
Last Updated: | October 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00465543 |
Health Authority: | Canada: Health Canada |
Nasal polyposis Mint tea Double-blind Placebo-controlled Crossover |
Rosmarinic acid Pathological Conditions, Anatomical Nasal Polyps Otorhinolaryngologic Diseases Polyps |
Anti-Inflammatory Agents Serine Proteinase Inhibitors Antioxidants Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents Enzyme Inhibitors Protective Agents Nose Diseases Pharmacologic Actions |
Protease Inhibitors Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Platelet Aggregation Inhibitors Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |