Efficacy of Homeopathic Nasal Formulation for Management of Experimental Rhinoviral Colds

Tracking Information
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; (submitted: July 31, 2006)	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	Complete list of historical versions of study NCT00358774 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: July 31, 2006)	The proportion of subjects who become infected.; The mean number of days that virus was shed for inoculated subjects (active vs placebo)
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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.
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: Cold incidence compared to placebo,; Symptom severity compared to placebo; Cold duration compared to placebo; Infection rate compared to placebo; Duration of virus shedding compared to placebo or; Amount of virus shedding compared to placebo
Study Type ICMJE	Interventional
Study Phase	Phase 1; Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Prevention
Condition ICMJE	Common Cold
Intervention ICMJE	Procedure: homeopathic nasal spray
Study Arms	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.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: July 31, 2006)	40
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	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: Be healthy based on medical history, physical and nasal examination; Be male or non-pregnant, non-lactating female (women of child-bearing potential must be using an acceptable form of contraception, including abstinence, as determined by the Investigator); Be between 18 - 60 years old; Be willing to refrain from taking nasal decongestants, antihistamines or cough/cold preparations (this includes dietary supplements and homeopathic preparations used specifically for cold/flu e.g., vitamin C, zinc, echinacea) within the 7 days prior to Day 0 and through Day 5; Be willing to refrain from taking any other medication (except contraceptive preparations, hormone replacement therapy, acne medication) within 2 days prior to Day 0 and through Day 5; Has read, signed and received a copy of the Informed Consent Form. Exclusion Criteria: Subjects will be excluded from the study if they: Are intolerant of nasal sprays; Require a medication on regular basis (3 or more times/week) except contraceptive preparations, hormone replacement therapy, acne medication; Have a history of chronic diseases such as respiratory (e.g., chronic rhinitis, sinusitis, asthma, chronic bronchitis, pneumonia, persistent or chronic cough, emphysema, breathing problems, excessive phlegm or mucus), cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, ophthalmic diseases requiring medication; Have a history of headache (e.g., frequent migraines, cluster headaches, 3+ headaches/week); Have had cold symptoms in the past 14 days; Are currently symptomatic with respiratory allergy; Have any clinically significant abnormalities of the upper (including history of nose bleeds, nasal abnormalities or other nasal pathology such as irreversible nasal mucosal hypertrophy or severe nasal septal deviation) or lower respiratory tract; Have used any investigational medication in the past 30 days; Are smokers; Have serum neutralizing antibody titer of >1 to RV16 at Pre-screening; Have a condition or is taking a medication that the Investigator and/or designee believes could jeopardize the safety of the subject, would interfere with the evaluation or confound the interpretation of the study results; Have positive urine pregnancy test (for female subjects only)
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 60 Years (Adult)
Accepts Healthy Volunteers	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	Not Provided
Responsible Party	University of Wisconsin, Madison
Study Sponsor ICMJE	University of Wisconsin, Madison
Collaborators ICMJE	Procter and Gamble
Investigators ICMJE	Principal Investigator: James E Gern, MD University of Wisconsin, Madison
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