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CompletedNCT00358774Updated Oct 14, 2015

Efficacy of Homeopathic Nasal Formulation for Management of Experimental Rhinoviral Colds

A Phase 1/2 interventional study of homeopathic nasal spray in Common Cold, sponsored by University of Wisconsin, Madison. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-14.

Sponsored by University of Wisconsin, Madison · Phase 1/2, Interventional, and Prevention

Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Common Cold

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Keywords

  • homeopathic
  • common cold
  • Research Subjects
03

In context

Common Cold

180 studies on the registry are indexed under Common Cold; 22 are open to participants now.

This study's enrollment of 40 is below the median of 167 across 151 interventional studies indexed under Common Cold.

Browse Common Cold studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.

Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

To be considered eligible for enrollment into this study, subject must:

  1. Be healthy based on medical history, physical and nasal examination
  2. 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)
  3. Be between 18 - 60 years old
  4. 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
  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
  6. Has read, signed and received a copy of the Informed Consent Form.

Exclusion criteria

Exclusion Criteria:

Subjects will be excluded from the study if they:

  1. Are intolerant of nasal sprays
  2. Require a medication on regular basis (3 or more times/week) except contraceptive preparations, hormone replacement therapy, acne medication
  3. 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
  4. Have a history of headache (e.g., frequent migraines, cluster headaches, 3+ headaches/week)
  5. Have had cold symptoms in the past 14 days
  6. Are currently symptomatic with respiratory allergy
  7. 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
  8. Have used any investigational medication in the past 30 days
  9. Are smokers
  10. Have serum neutralizing antibody titer of >1 to RV16 at Pre-screening
  11. 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
  12. Have positive urine pregnancy test (for female subjects only)
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
40 participants

Interventions

  • Procedurehomeopathic nasal spray
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. The proportion of subjects who become infected.

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

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00358774
Lead sponsor
University of Wisconsin, Madison
Collaborators
Procter and Gamble
Responsible party
Sponsor
First posted
Aug 1, 2006
Start date
Mar 2001
Primary completion
Mar 2002
Completion
Mar 2002
Last update
Oct 14, 2015

Study contacts

James E Gern, MD
principal investigator · University of Wisconsin, Madison
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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