Efficacy and Safety of Enisamium Iodide for the Treatment of Acute Respiratory Viral Infections, Including Influenza.
Status:
Completed
Trial end date:
2010-05-15
Target enrollment:
Participant gender:
Summary
This randomized, single blind clinical study was conducted to investigate the clinical
efficacy and safety of the drug Amizon (enisamium iodide), in comparison with placebo for the
treatment of patients with acute respiratory viral infections (ARVI), including influenza.
Enisamium iodide is an antiviral small molecule.
Adult patients were enrolled and randomised into 2 groups. On the first day of the onset of
symptoms of ARVI, one group of patients took Amizon tablets (active ingredient enisamium
iodide) for 7 days; the other group of patients took matching placebo tablets for 7 days.
Examination and observation of all participants was done for up to 14 days after the first
intake of the study drug.
The effect of treatment was assessed by subjective reporting of the symptoms of ARVI and
influenza, using a predefined symptom scale score system.
Objective assessment was performed by measuring vitals signs, laboratory tests (including
blood and urine assessment), as well as evaluating the immune status (including measuring the
relative concentration of interferon and immunoglobulins).