Clinical TrialID 757

Pilot Study to Determine Efficacy of Cyclamen Europaeum Extract Nasal Spray in Patients With Acute Sinusitis

NCT00552773

ACUTE SINUSITIS

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Record Fields

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Clinical Trial Id
757
Evidence Id
757
Core Evidence Id
757
Source Clinical Trial Id
767
Herb2 Clinical Trial Id
HBCT000767
Nct Id
NCT00552773
Title
Pilot Study to Determine Efficacy of Cyclamen Europaeum Extract Nasal Spray in Patients With Acute Sinusitis
Status
Completed
Phase
Study Result
No
Study Condition
ACUTE SINUSITIS
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DRUG: Cyclamen Europaeum
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Quadruple
Intervention Purpose
Treatment
Gender
All
Age
Adult, Older_Adult
Enrollment
48
Outcome Measure
Subjective: The mean change in Total Symptom Score (TSS). Objective: The mean change in the percent of sinus occlusion as determined by CT scans., 1 year
Sponsor Collaborator
Dey
Funded By
INDUSTRY
Location
Alliance Clinical Research, Birmingham, Alabama, 35215, United States|Center of Research Excellence, LLC, Oxford, Alabama, 36206, United States|Clinical Research Connections, Jonesboro, Arkansas, 72401, United States|Southeast Clinical Research, Gainsville, Florida, 32601, United States|Orlando Rangel, MD, PA, Tampa, Florida, 33607, United States|Premier Health Research Center, Winter Haven, Florida, 33880, United States|Peak Medical Research, LLC, Owensboro, Kentucky, 42303, United States|Four Rivers Clinical Research, Inc., Paducah, Kentucky, 42003, United States|Las Vegas Physicians Research Group, Henderson, Nevada, 89052, United States|LAND Clinical Studies, LLC, West Caldwell, New Jersey, 07006, United States|Health Science Research Center, Cortland, New York, 13045, United States|Medical Research Associates of Central ew York, PLLC, North Syracuse, New York, 13212, United States|American Institute of Healthcare and Fitness Clinical Research, Raleigh, North Carolina, 27615, United States|Jones Family Pratice, Shelby, North Carolina, 28150, United States|Memorial Clinical Research, Oklahoma City, Oklahoma, 73134, United States|Greenville Pharmaceutical Research, Greenville, South Carolina, 28615, United States|ADAC Research, PA, Greenville, South Carolina, 29607, United States|Carolina Research, Orangeberg, South Carolina, 29118, United States|Austin Ear, Nose and Throat Clinic, Austin, Texas, 78707, United States|West Lake Ffamily Practice/Time Point Clinical Research, Austin, Texas, 78746, United States|San Antonio Ear, Nose & Throat Research, San Antonio, Texas, 78229, United States|Live Oak Allergy and Asthma Clinic, San Antonio, Texas, 78233, United States|Clinical Health Research LLC, Sugar Land, Texas, 77479, United States|Wasatch Clinical Research, LLC, Salt Lake City, Utah, 84107, United States|Virginia Adult and Pediatric Allergy and Asthma, PC, Richmond, Virginia, 23229, United States
Other Id
434-083
Start Date
2007-11
Primary Completion Date
2008-09
Completion Date
2009-12
First Posted
2007-11-02
Results First Posted
Last Update Posted
2013-06-04
Study Document
Study Url
https://clinicaltrials.gov/study/NCT00552773
Title Cn
Title En
Pilot Study to Determine Efficacy of Cyclamen Europaeum Extract Nasal Spray in Patients With Acute Sinusitis
Bilingual Status
semi_complete