The purpose of this study is: * to assess clinical efficiency of Ergoferon for treatment of influenza * to assess safety of Ergoferon for treatment of influenza * to compare efficiency of Ergoferon and Tamiflu for treatment of influenza
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
161
Safety and Efficiency of Ergoferon in treatment of Influenza
Safety and Efficiency in treatment of Influenza
Federal State Budgetary Institution "Scientific Research Institute for Vaccines and Serum named after I.I.Mechnikov" of Russian Academy of Medical Science
Moscow, Russia
State Budgetary Educational Institution of Higher Professional Education "The Russian National Research Medical University named after N.I. Pirogov" of Ministry of Health and Social Development of Russian Federation
Moscow, Russia
Percentage of Patients With Normal Body Temperature
Axillary temperature (morning and evening) decline to or below 37.0 ºС (without subsequent increase during ≥24 h)
Time frame: Day 1 to Day 5
Percentage of Patients With Resolution of Influenza Symptoms
Assessment of the proportion of subjects with no clinical symptoms of the disease (fever, common and respiratory symptoms) at Study Day 7 (Visit 3). The severity of influenza symptoms was assessed by a physician with 0 to 3 point scale, where 0 means no symptom, 1=mild symptom, 2=moderate symptom, and 3=severe symptom
Time frame: on the day 7 of the observation
Time to Resolution of the Influenza
Time to resolution was considered as time to the absence of any flu symptom. Absence of symptoms was considered as axillary temperature decline to or below 37.0 ºС without subsequent rise, resolution of the common and respiratory symptoms. The duration of a symptom was defined by physician recorded presence/absence of the symptoms during a physical examination at Day 1 to Day 7.
Time frame: Day 1 to Day 7
Mean Body Temperature
The axillary temperature was assessed during a physical examination at Day 1, 3 and 7; axillary temperature was assessed in degrees (Celsius, °С)
Time frame: on days 1, 3 and 7 of the observation
Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)
The severity of influenza symptoms was assessed during a physical examination at Day 1, 3 and 7; common (10 symptoms) and respiratory (5 symptoms) symptom's total score was assessed with using the point scale: 0=No symptom; 1=Mild symptom; 2=Moderate symptom ; 3=Severe symptom. The Common Symptoms total score ranged from 0 (no symptoms) to 30 (severe symptoms). The Respiration Symptoms total score ranged from 0 (no symptoms) to 15 (severe symptoms)
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Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation
Moscow, Russia
St. Petersburg State Budgetary Health Care Institution "City Polyclinic №106"
Saint Petersburg, Russia
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic № 117"
Saint Petersburg, Russia
State Budgetary Educational Institution of Higher Professional Education "Smolensk State Medical Academy" of Ministry of Health and Social Development of Russian Federation
Smolensk, Russia
State Educational Institution of Higher Professional Education "Voronezh State Academy named after N.N. Burdenko" of Ministry of Health and Social Development of Russian Federation
Voronezh, Russia
State Budgetary Educational Institution of Higher Professional Education "Yaroslavl State Medical Academy" of Ministry of Health and Social Development of Russian Federation
Yaroslavl, Russia
Time frame: on days 1, 3 and 7 of the observation
The Number of the Antipyretic Intake
A subject recorded the number of antipyretic intake in patient diary.
Time frame: Day 1 to Day 5
Change in the Patient's Quality of Life.
The quality of life was assessed in influenza patients at baseline and at the end of the treatment period using the European Quality of Life Questionnaire (EQ5D) measuring the health status by five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression (each dimension is assessed by 1 to 3 point scale; the minimum score 5 points refers to the best status, 15 points refers to the worst status).
Time frame: Day 7 vs. Day 1
Change in the Subjective Health Status
The patient subjective health status assessment was based on Visual Analogue Scale - VAS). VAS includes a rating of current health status from 0 (worst) to 100 (best).
Time frame: Day 7 vs. Day 1
Percentage of Patients With Complications of the Influenza
Pneumonia, sinusitis, otitis media are examples of the influenza complications
Time frame: Day 1 to Day 7