Status:
COMPLETED
Efficacy of Homeopathic Nasal Formulation for Management of Experimental Rhinoviral Colds
Lead Sponsor:
University of Wisconsin, Madison
Collaborating Sponsors:
Procter and Gamble
Conditions:
Common Cold
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2001
Trial Type :
INTERVENTIONAL
End Date :
March 1 2002
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00358774
Start Date
March 1 2001
End Date
March 1 2002
Last Update
October 14 2015
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