Efficacy of Homeopathic Nasal Formulation for Management of Experimental Rhinoviral Colds
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ClinicalTrials.gov Identifier: NCT00358774 |
Recruitment Status :
Completed
First Posted : August 1, 2006
Last Update Posted : October 14, 2015
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Tracking Information | ||||
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First Submitted Date ICMJE | July 28, 2006 | |||
First Posted Date ICMJE | August 1, 2006 | |||
Last Update Posted Date | October 14, 2015 | |||
Study Start Date ICMJE | March 2001 | |||
Actual Primary Completion Date | March 2002 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
The proportion of subjects who become infected and show the presence of a cold.(active vs placebo) | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Efficacy of Homeopathic Nasal Formulation for Management of Experimental Rhinoviral Colds | |||
Official Title ICMJE | A Double-blind, Placebo-controlled Trial to Test the Efficacy of Homeopathic Nasal Formulation for the Management of Experimental Rhinoviral Colds in an Outpatient Setting | |||
Brief Summary | Common colds affect many people and are the cause of bothersome symptoms such as runny or stuffy nose, sore throat, headache and sneezing. Common colds can also cause more severe illnesses in certain groups of people like the elderly, people with chronic lung diseases such as asthma. This study is designed to test whether a non-drug (homeopathic) nasal spray will reduce the incidence of colds, decrease cold related symptoms or shorten the length of the cold. |
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Detailed Description | Common colds are the most frequent type of respiratory infection, and although the clinical manifestations are usually not life threatening or debilitating, they cause annoying symptoms such as nasal congestion, rhinorrhea, malaise, sore throat and sneezing, that can interfere with activities of daily living. Furthermore, colds can cause more severe illnesses in certain people including: infants, the elderly, and people with asthma, chronic lung diseases, or immune deficiency. This clinical trial is designed to test whether a new homeopathic formulation has beneficial effects on the management of common colds that have been induced by inoculation of rhinovirus into the nose of healthy subjects. The objective of this research clinical study is to evaluate the effectiveness of a homeopathic nasal formulation for the management of experimentally-induced common colds as indicated by a reduction in:
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention |
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Condition ICMJE | Common Cold | |||
Intervention ICMJE | Procedure: homeopathic nasal spray | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE |
40 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | March 2002 | |||
Actual Primary Completion Date | March 2002 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: To be considered eligible for enrollment into this study, subject must:
Exclusion Criteria: Subjects will be excluded from the study if they:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00358774 | |||
Other Study ID Numbers ICMJE | 2001-089 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | University of Wisconsin, Madison | |||
Study Sponsor ICMJE | University of Wisconsin, Madison | |||
Collaborators ICMJE | Procter and Gamble | |||
Investigators ICMJE |
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PRS Account | University of Wisconsin, Madison | |||
Verification Date | October 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |