The purpose of this study is: * to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper respiratory tract infections in children; * to assess clinical efficacy of the liquid dosage form of Ergoferon for treatment acute upper respiratory tract infections in children.
The overall duration of a patient's participation in the trial is 6 days (screening/randomization, therapy onset - day 1; study therapy period - 5 days; follow-up period-1 day).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
306
State Educational Institution of Higher Professional Education "Moscow State Medical Academy named after I.M. Sechenov"
Moscow, Russia
State Budgetary Educational Institution of Higher Professional Education Novosibirsk State Medical University of Ministry of Health of Russian Federation
Novosibirsk, Russia
Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data)
Based on the data mentioned in a patient's diary
Time frame: On day 2, 3 and 4 of observation
Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline)
Time frame: baseline and days 2, 3, 4 and 5 of observation
Percentage of Patients With Normal Body Temperature (≤37.0ºС)
Axillary temperature (morning and evening) decline to or below 37.0 ºС
Time frame: On day 2, 3, 4, 5 of observation
Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom. The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С). Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Day 3; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 2-5.
Time frame: on Days 2, 3, 4, 5 of Observation
Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data
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Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"
Perm, Russia
St. Peterburg State Health Care Institution "Child Health City Hospital №45 of the Nevsky Region"
Saint Peterburg, Russia
State Budgetary Health Care Institution "Сity Child Health Polyclinic №44"
Saint Petersburg, Russia
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44"
Saint Petersburg, Russia
State Budgetary Educational Institution of Higher Professional Education "St. Petersburg State Pediatric Medical Academy" of Ministry of Health of Russian Federation
Saint Petersburg, Russia
Limited Liability Company "Alliance Biomedical-Russian group"
Saint Petersburg, Russia
State Health Care Institution "Child Health City Hospital №22"
Saint Petersburg, Russia
State Budgetary Educational Institution of Higher Professional Education " Yaroslavl State Medical Academy" of Ministry of Health
Yaroslavl, Russia
...and 1 more locations
Acute respiratory infection (ARI) symptoms include 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The ARI symptoms was recorded by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5.
Time frame: baseline and days 2, 3, 4 and 5 of observation
Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS)
The Total Symptom Score (TSS) was based on the severity of each of acute respiratory infection (ARI) symptom. The TSS includes 13 symptoms: Body temperature / fever, Non-specific ARI symptoms (headache, chills, sweating, weakness, muscle pain, drowsiness), Nasal/Throat/Chest symptoms (Runny nose, Nasal congestion, Sneezing, Sore throat, Hoarseness, Cough, Chest pain/Tightness of the chest). The severity of Non-specific and Nasal/Throat/Chest symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). The Fever was scored on a symptom severity scale 0 = no symptom (≤37,30С); 1 = mild symptom (37,4-38,00С); 2 = moderate symptom (38,1-39,00); 3 = severe symptom (≥39,10С). Minimum score=0; maximum score=39. The severity of ARI symptoms was recorded: 1) by the doctors on the case record form on Days 1, 3, 6; 2) by one of the patient's parents/adopter on a diary card twice a day (morning and evening) on Days 1-5.
Time frame: On days 1-6 of observation
Number of Intakes of Antipyretics if Indicated
Based on data mentioned in a patient's diary
Time frame: On day 1, 2, 3, 4 and 5 of the treatment
Percentage of Patients With Exacerbation of the Disease Course
The development of disease complications requiring antibiotics administration or hospitalization
Time frame: On days 1-6 of observation