search
Back to results

Efficacy of Homeopathic Nasal Formulation for Management of Experimental Rhinoviral Colds

Primary Purpose

Common Cold

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
homeopathic nasal spray
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Common Cold focused on measuring homeopathic, common cold, Research Subjects

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

    Outcomes

    Primary Outcome Measures

    The proportion of subjects who become infected and show the presence of a cold.(active vs placebo)

    Secondary Outcome Measures

    The proportion of subjects who become infected.
    The mean number of days that virus was shed for inoculated subjects (active vs placebo)

    Full Information

    First Posted
    July 28, 2006
    Last Updated
    October 13, 2015
    Sponsor
    University of Wisconsin, Madison
    Collaborators
    Procter and Gamble
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00358774
    Brief Title
    Efficacy of Homeopathic Nasal Formulation for Management of Experimental Rhinoviral Colds
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2001 (undefined)
    Primary Completion Date
    March 2002 (Actual)
    Study Completion Date
    March 2002 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Wisconsin, Madison
    Collaborators
    Procter and Gamble

    4. Oversight

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Common Cold
    Keywords
    homeopathic, common cold, Research Subjects

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    40 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    homeopathic nasal spray
    Primary Outcome Measure Information:
    Title
    The proportion of subjects who become infected and show the presence of a cold.(active vs placebo)
    Secondary Outcome Measure Information:
    Title
    The proportion of subjects who become infected.
    Title
    The mean number of days that virus was shed for inoculated subjects (active vs placebo)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James E Gern, MD
    Organizational Affiliation
    University of Wisconsin, Madison
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Homeopathic Nasal Formulation for Management of Experimental Rhinoviral Colds

    We'll reach out to this number within 24 hrs