Pilot Study to Determine Efficacy of Cyclamen Europaeum Extract Nasal Spray in Patients With Acute Sinusitis
NCT ID: NCT00552773
Last Updated: 2013-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2007-11-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cyclamen Europaeum
Cyclamen Europaeum
Nasal spray 10% (V/V),one spray per nostril daily for 7 days.
Placebo
Cyclamen Europaeum
Nasal spray 10% (V/V),one spray per nostril daily for 7 days.
Interventions
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Cyclamen Europaeum
Nasal spray 10% (V/V),one spray per nostril daily for 7 days.
Eligibility Criteria
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Inclusion Criteria
2. Must be symptomatic on the basis of subject assessments of total sympton score.
3. Evidence of mucopurulence on nasal endoscopy
4. Evidence of inflammation upon nasal endoscopy
5. CT scan with radiographic signs of acute sinusitis
6. Able to complete all study activities or procedures through the end of the study, including all visits and tests, and capable of selfadministration of study medication
7. Agree to abide by the study protocol and its restrictions
Exclusion Criteria
2. Known hypersensitivity to Cyclamen, Primula, or other Primulaceae
3. Serious unstable comorbidity such as malignancy (other than squamous or basal cell carcinoma of the skin) or sever renal or hepatic disease.
4. Abnormal screening laboratory/imaging test results
5. Condition(s) that compromise the ability to either administer the agent or assess the risks/benefits (eg mucocele, choanal polyp, Stage 4 polyposis or cyst extending below the inferior turbinate, deviated septum, facial trauma, or birth defect)
6. Expansile mass or bony erosion on sinus radiograph
7. Females who are pregnant, planning to become pregnant or currently breastfeeding.
8. History of viral upper respiratory infection (URI) in the past 2 weeks
9. Temperature greater than 102.5°F
10. Facial or periorbital edema
11. Local complications including orbital cellulitis; acute abnormalities of extraocular movements; cavernous vein thrombosis; dental or facial abscess
12. Altered mental status
13. Recent nasal or sinus surgery (within 3 months or less) or planned surgery within the next 3 months
14. Use of intranasal antibiotics within the previous 30 days or systemic antibiotics within the previous 15 days
15. Use of oral and/or topical nasal decongestants within the previous 7 days
16. Had radiation therapy or chemotherapy within the previous 12 months
17. Have used an investigational drug or device within 30 days prior to screening
18. Have a history of illegal drug or alcohol abuse within the past 5 years
19. Have major unstable organ system disease that could place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives Subjects who have asthma, seasonal and/or perennial allergic rhinitis will be allowed to enter the study.
18 Years
70 Years
ALL
No
Sponsors
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Dey
INDUSTRY
Responsible Party
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Principal Investigators
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Angelique Barreto, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Clinical Reasearch, OK
Locations
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Alliance Clinical Research
Birmingham, Alabama, United States
Center of Research Excellence, LLC
Oxford, Alabama, United States
Clinical Research Connections
Jonesboro, Arkansas, United States
Southeast Clinical Research
Gainsville, Florida, United States
Orlando Rangel, MD, PA
Tampa, Florida, United States
Premier Health Research Center
Winter Haven, Florida, United States
Peak Medical Research, LLC
Owensboro, Kentucky, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, United States
Las Vegas Physicians Research Group
Henderson, Nevada, United States
LAND Clinical Studies, LLC
West Caldwell, New Jersey, United States
Health Science Research Center
Cortland, New York, United States
Medical Research Associates of Central ew York, PLLC
North Syracuse, New York, United States
American Institute of Healthcare and Fitness Clinical Research
Raleigh, North Carolina, United States
Jones Family Pratice
Shelby, North Carolina, United States
Memorial Clinical Research
Oklahoma City, Oklahoma, United States
Greenville Pharmaceutical Research
Greenville, South Carolina, United States
ADAC Research, PA
Greenville, South Carolina, United States
Carolina Research
Orangeberg, South Carolina, United States
Austin Ear, Nose and Throat Clinic
Austin, Texas, United States
West Lake Ffamily Practice/Time Point Clinical Research
Austin, Texas, United States
San Antonio Ear, Nose & Throat Research
San Antonio, Texas, United States
Live Oak Allergy and Asthma Clinic
San Antonio, Texas, United States
Clinical Health Research LLC
Sugar Land, Texas, United States
Wasatch Clinical Research, LLC
Salt Lake City, Utah, United States
Virginia Adult and Pediatric Allergy and Asthma, PC
Richmond, Virginia, United States
Countries
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Other Identifiers
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434-083
Identifier Type: -
Identifier Source: org_study_id
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