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Mint Tea for the Treatment of Nasal Polyps

Primary Purpose

Nasal Polyps

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Mint tea high in rosmarinic acid

Mint tea low in rosmarinic acid

About this trial

This is an interventional treatment trial for Nasal Polyps focused on measuring Nasal polyposis, Mint tea, Double-blind, Placebo-controlled, Crossover

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects who are male or female aged 18 years or older.
Subjects who have signed an informed consent agreement.
Subjects with a history of nasal polyp symptoms during the previous 12 months.

Exclusion Criteria:

Subjects with severe nasal polyps requiring immediate surgery.
Subjects presenting with unilateral polyps.
Subjects who have undergone surgery to treat their nasal polyps (nasal polypectomy) within one year prior to visit one.
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.
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.
Subjects having cystic fibrosis, Young's syndrome, primary ciliary dyskinesia, known HIV infection or alcohol abuse.
Subjects with clinically significant, uncontrolled evidence of cardiovascular, neurological, hepatic, renal, respiratory, or any other medical condition that may interfere with the study.
Subjects with a recent history (within six months) of a clinically significant psychiatric disorder other than mild depression.
Subjects who have any clinically relevant deviation from normal in the general physical examination.
Subjects who have received any depot, systemic or oral corticosteroid in the previous three months prior to the start of the study.
Subjects who are unable to cease treatment with intranasal steroids four weeks prior to Visit one.
Subjects with a known hypersensitivity to mint.
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.
Subjects who are unable to follow the instructions within this protocol or known inability to attend all clinic visits within the intervals stated.
Subjects who have participated in a clinical trial involving an investigational or marketed drug within four weeks of visit one.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Arm Label

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Nasal polyposis quality of life questionnaire

Nasal patency as assessed by use of the Clement-Clarke peak nasal inspiratory flow meter (PNIF)

Secondary Outcome Measures

Nasal lavage eosinophils.

Peripheral blood eosinophils

Diary symptom scores.

Nasal polyp size on visual inspection.

Subjects Global Assessment of symptoms

Full Information

NCT ID

NCT00465543

First Posted

April 23, 2007

Last Updated

December 8, 2011

Sponsor

Hamilton Health Sciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00465543

Brief Title

Mint Tea for the Treatment of Nasal Polyps

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasal Polyps

Keywords

Nasal polyposis, Mint tea, Double-blind, Placebo-controlled, Crossover

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

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).

Arm Title

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Mint tea high in rosmarinic acid

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Mint tea low in rosmarinic acid

Intervention Description

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.

Primary Outcome Measure Information:

Title

Nasal polyposis quality of life questionnaire

Time Frame

Visits 2, 3,4,5

Title

Nasal patency as assessed by use of the Clement-Clarke peak nasal inspiratory flow meter (PNIF)

Time Frame

Daily

Secondary Outcome Measure Information:

Title

Nasal lavage eosinophils.

Time Frame

Visits 1,2,3,4,5

Title

Peripheral blood eosinophils

Time Frame

Visits 2,3,4,5

Title

Diary symptom scores.

Time Frame

Daily

Title

Nasal polyp size on visual inspection.

Time Frame

Visits 1,2,3,4,5

Title

Subjects Global Assessment of symptoms

Time Frame

Visits 3 and 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who are male or female aged 18 years or older. Subjects who have signed an informed consent agreement. Subjects with a history of nasal polyp symptoms during the previous 12 months. Exclusion Criteria: Subjects with severe nasal polyps requiring immediate surgery. Subjects presenting with unilateral polyps. Subjects who have undergone surgery to treat their nasal polyps (nasal polypectomy) within one year prior to visit one. 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. 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. Subjects having cystic fibrosis, Young's syndrome, primary ciliary dyskinesia, known HIV infection or alcohol abuse. Subjects with clinically significant, uncontrolled evidence of cardiovascular, neurological, hepatic, renal, respiratory, or any other medical condition that may interfere with the study. Subjects with a recent history (within six months) of a clinically significant psychiatric disorder other than mild depression. Subjects who have any clinically relevant deviation from normal in the general physical examination. Subjects who have received any depot, systemic or oral corticosteroid in the previous three months prior to the start of the study. Subjects who are unable to cease treatment with intranasal steroids four weeks prior to Visit one. Subjects with a known hypersensitivity to mint. 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. Subjects who are unable to follow the instructions within this protocol or known inability to attend all clinic visits within the intervals stated. Subjects who have participated in a clinical trial involving an investigational or marketed drug within four weeks of visit one. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul K. Keith

Organizational Affiliation

Hamilton Health Sciences Corporation, McMaster Site

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

7508349

Citation

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.

Results Reference

background

PubMed Identifier

16767798

Citation

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.

Results Reference

background

PubMed Identifier

14988517

Citation

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.

Results Reference

background

PubMed Identifier

2262649

Citation

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.

Results Reference

background

Citation

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)

Results Reference

background

Citation

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)

Results Reference

background

PubMed Identifier

886201

Citation

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.

Results Reference

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Mint Tea for the Treatment of Nasal Polyps

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