The aim of the study is to evaluate the safety of the intake of EPs® 7630 during a long-term (4 months) medication. The protective effects of EPs®7630 and its effects during a cold episode will also be studied.
The main objective of this clinical trial is to evaluate the safety of EPs® 7630 intake - used as continuous protection and at the onset of cold symptoms - in adult participants during a long-term (4 months) medication. Due to the sparseness of empirical data in the population and this setting, no confirmatory hypotheses are formulated and the data will be analysed descriptively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
720
Cardiff University, Common Cold Centre, Cardiff School of Biosciences
Cardiff, Wales, United Kingdom
Occurrence of Adverse Drug Reactions (ADRs)
Time frame: during the 4 months treatment
Occurrence of Adverse Events (AEs) during the 4 months treatment
Time frame: Adverse events will be documented during the 4 months treatment period.
Protective effects
Time to onset of first common cold symptoms, time between last common cold episode prior to trial entry and first cold episode during the trial, total number of common cold episodes, total number of participants with at least one / more than one common cold episode
Time frame: Protective effects will be evaluated during the 4 months treatment period.
Effects during a cold episode
Mean cold episode duration (in days), cumulative episode days, number of co-medicated cold episodes, number of patients with respiratory complications due to common cold, development of the total cold symptom score and of single symptoms during a cold episode
Time frame: Treatment effects on common cold symptoms will be documented for 14 days after onset of first common cold symptom
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