Mint Tea for the Treatment of Nasal Polyps

NCT00465543 | Completed Phase 2

• 1 other identifier: 07-010
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nasal Polyps

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Nasal polyposis quality of life questionnaire

  Visits 2, 3,4,5

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

  Daily

Secondary Outcomes (5)

• Nasal lavage eosinophils.

  Visits 1,2,3,4,5

• Peripheral blood eosinophils

  Visits 2,3,4,5

• Diary symptom scores.

  Daily

• Nasal polyp size on visual inspection.

  Visits 1,2,3,4,5

• Subjects Global Assessment of symptoms

  Visits 3 and 5

Study Arms (2)

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).

Other: Mint tea low in rosmarinic acid

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.

Other: Mint tea high in rosmarinic acid

Interventions

Mint tea high in rosmarinic acid OTHER

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.

I

Mint tea low in rosmarinic acid OTHER

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.

II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Related Publications (7)

• 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.

  PMID: 7508349 BACKGROUND

• 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.

  PMID: 16767798 BACKGROUND

• 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.

  PMID: 14988517 BACKGROUND

• 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.

  PMID: 2262649 BACKGROUND

• 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)

  BACKGROUND

• 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)

  BACKGROUND

• 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.

  PMID: 886201 BACKGROUND

MeSH Terms

Conditions

Nasal Polyps

Interventions

Rosmarinic Acid

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Depsides; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Cinnamates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Paul K. Keith

  Hamilton Health Sciences Corporation, McMaster Site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 25, 2007
• Study Start: May 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 9, 2011

Record last verified: 2011-12