Efficacy of Homeopathic Nasal Formulation for Management of Experimental Rhinoviral Colds

NCT00358774 | Completed Phase 1

• 1 other identifier: 2001-089
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Common Cold

Keywords

homeopathic; common cold; Research Subjects

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• The proportion of subjects who become infected.

• The mean number of days that virus was shed for inoculated subjects (active vs placebo)

Interventions

homeopathic nasal spray PROCEDURE

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Procter and Gamble: collaborator

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• James E Gern, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2006
• First Posted: August 1, 2006
• Study Start: March 1, 2001
• Primary Completion: March 1, 2002
• Study Completion: March 1, 2002
• Last Updated: October 14, 2015

Record last verified: 2015-10