Status:
COMPLETED
Mint Tea for the Treatment of Nasal Polyps
Lead Sponsor:
Hamilton Health Sciences Corporation
Conditions:
Nasal Polyps
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 rosmarin...
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....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00465543
Start Date
May 1 2007
End Date
June 1 2008
Last Update
December 9 2011
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