Common Cold Clinical Trial
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.
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
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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