Purpose of the study: * To assess efficacy of Anaferon for children liquid dosage form in the treatment of acute upper respiratory tract infections. * To assess safety of Anaferon for children liquid dosage form in the treatment of acute upper respiratory tract infections.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
142
10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
LLC Center for Vaccine Prevention "DIAVAKS"
Moscow, Russia
Municipal Health Care Institution "City Child Health Clinical Polyclinic №5"
Perm, Russia
St. Petersburg State Budgetary Health Care Institution "Сity Polyclinic №44"
Saint Petersburg, Russia
Average Illness Duration (the Interval Between the Start of the Trial Treatment and the Time When Recovery/Improvement - Based on Patient Diary Data)
based on patient diary data
Time frame: From the time of randomization until the time of recovery/improvement, assessed up to 14 days
Severity of the Disease Within 5 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS) at 1-5 Days (According to the Diary of the Patient).
The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI 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: On days 1-5 of observation
Percentage of Patients With Recovery on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)
based on patient diary data
Time frame: On Days 2-5 of the treatment
Average Duration of Fever (i.e. Body Temperature >37.3°С)
based on patient diary data
Time frame: From the time of randomization until the time of normal body temperature, assessed up to 14 days
Mean Body Temperatures, Measured in the Morning and Evening on Days 2-5 (Based on Patient Diary Data)
based on patient diary data
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St. Petersburg State Health Care Institution "Children's City Polyclinic No. 45 Nevsky District"
Saint Petersburg, Russia
Alliance Biomedical-Russian Group LLC
Saint Petersburg, Russia
St. Petersburg State Budgetary Healthcare Institution "Children's City Hospital No. 22"
Saint Petersburg, Russia
Federal State Budgetary Educational Institutionof Higher Education "Yaroslavl State Medical University" of the Ministry of Healthcare of the Russian Federation
Yaroslavl, Russia
Time frame: On Days 2-5 of the treatment
Percentage of Patients With Body Temperature ≤37.30С on Days 2-5 of Observation
based on patient diary data
Time frame: On Days 2-5 of observation
Total Symptom Score on Days 3 and 6 of Observation Based on the Results of Pediatrician's Examination
The Total Symptom Score (TSS) was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6.
Time frame: On Days 1, 3, 6 of the treatment
Severity of the Disease Within 5 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS) on Days 1, 3, 6 (According to the Results of Pediatrician's Examination)
The TSS was based on the severity of each of acute upper respiratory tract infection (URTI) symptom. The TSS includes 11 symptoms: Body temperature / fever, Non-specific URTI symptoms (Decreased activity / Malaise, Impaired appetite / refusal of feeding, Painful appearance, Sleep disturbance) and Nose /Throat symptoms (Runny nose, Nasal congestion, Sneezing, Hoarseness, Sore throat, Cough). The severity of each URTI symptom was scored on a symptom severity scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms). Minimum score=0; maximum score=33. The severity of URTI symptoms was recorded by the study researchers (pediatricians) on the case record form on Days 1, 3, 6.
Time frame: on Days 1, 3, 6
Number of Antipyretic Use (for Prescribed Indications) on Days 1-5 of Treatment (Based on Patient Diary Data)
based on patient diary data
Time frame: on Days 1-5 of treatment
Percentage of Patients With Complications of Illness, Including Those Requiring Antibiotic Administration or Hospitalization) for 14 Days of Observation
Time frame: From the time of randomization up to 14 days