Efficacy of Homeopathic Nasal Formulation for Management of Experimental Rhinoviral Colds
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00358774 |
Recruitment Status :
Completed
First Posted : August 1, 2006
Last Update Posted : October 14, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Common Cold | Procedure: homeopathic nasal spray | Phase 1 Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Prevention |
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 Start Date : | March 2001 |
Actual Primary Completion Date : | March 2002 |
Actual Study Completion Date : | March 2002 |
- The proportion of subjects who become infected and show the presence of a cold.(active vs placebo)
- The proportion of subjects who become infected.
- The mean number of days that virus was shed for inoculated subjects (active vs placebo)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358774
Principal Investigator: | James E Gern, MD | University of Wisconsin, Madison |
Responsible Party: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00358774 |
Other Study ID Numbers: |
2001-089 |
First Posted: | August 1, 2006 Key Record Dates |
Last Update Posted: | October 14, 2015 |
Last Verified: | October 2015 |
homeopathic common cold Research Subjects |
Common Cold Picornaviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |