Mint Tea for the Treatment of Nasal Polyps

Nasal Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465543
• Other study ID #: 07-010
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2007
• Last updated: December 8, 2011
• Start date: May 2007
• Est. completion date: June 2008

Study information

• Verified date: December 2011
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects who are male or female aged 18 years or older.

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:

1. Subjects with severe nasal polyps requiring immediate surgery.

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.

Related Conditions & MeSH terms

• Nasal Polyps
• Polyps

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

References & 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. — View 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)

Keith PK, Conway M, Evans S, Edney P, Jennings B, Andersson B, Dolovich J. A double-blind comparison of intranasal budesonide dry powder vs placebo in nasal polyposis. J.Allergy Clin.Immunol. 1995;95:204(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)

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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal polyposis quality of life questionnaire		Visits 2, 3,4,5
Primary	Nasal patency as assessed by use of the Clement-Clarke peak nasal inspiratory flow meter (PNIF)		Daily
Secondary	Nasal lavage eosinophils.		Visits 1,2,3,4,5
Secondary	Peripheral blood eosinophils		Visits 2,3,4,5
Secondary	Diary symptom scores.		Daily
Secondary	Nasal polyp size on visual inspection.		Visits 1,2,3,4,5
Secondary	Subjects Global Assessment of symptoms		Visits 3 and 5