Common ColdPhase 1/2NCT00358774
Efficacy of Homeopathic Nasal Formulation for Management of Experimental Rhinoviral Colds
A Phase 1/2 study testing homeopathic nasal spray in people with Common Cold, run by University of Wisconsin, Madison.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold
- What is being tested?
- homeopathic nasal spray
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2001to Mar 2002
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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)
About this study
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
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
- Conditions
- Common Cold
- Being tested
- homeopathic nasal spray
- Keywords
- homeopathic, common cold, Research Subjects
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
homeopathic nasal sprayProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startMar 2001
- Primary completionMar 2002
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Sponsor
- Investigators
- James E Gern, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358774
- Sponsor's protocol ID
- 2001-089
- Status last verified
- Oct 2015
- First submitted
- 28 Jul 2006
- Last updated
- 14 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00358774
- Acronym / sponsor ID
- 2001-089
- Conditions
- Common Cold
- Keywords
- homeopathic, common cold, Research Subjects
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- Mar 2001
- Primary completion
- Mar 2002 (actual)
- Study completion
- Mar 2002 (actual)
- First posted
- 1 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| homeopathic nasal spray | Procedure or surgery | – |
Primary outcome
The proportion of subjects who become infected and show the presence of a cold.(active vs placebo)
2 secondary outcomes
The proportion of subjects who become infected.
The mean number of days that virus was shed for inoculated subjects (active vs placebo)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James E Gern, MD principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing homeopathic nasal spray in people with Common Cold, run by University of Wisconsin, Madison.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects who become infected and show the presence of a cold.(active vs placebo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.