| Primary | 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 | | Posted | | Number | | percentage of participants | | On day 2, 3 and 4 of observation | | | | ID | Title | Description |
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| OG000 | Ergoferon in Liquid Dosage Form | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | | OG001 | Placebo | Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. |
| | | Title | Denominators | Categories |
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| Day 2 | | | | Day 3 | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Global Test Statistic | See O'Brien 1984, Pocock 1997. | 0.016 | | | | | | | | | | | | | | Superiority | | |
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| Secondary | Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline) | | Per Protocol set. The morning temperature in 13 patients (7 in the Ergoferon group and 6 in the placebo group) was excluded from the analysis due to mistakes in diaries. | Posted | | Mean | Standard Deviation | °C | | baseline and days 2, 3, 4 and 5 of observation | | | | ID | Title | Description |
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| OG000 | Ergoferon in Liquid Dosage Form | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | | OG001 | Placebo | Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. |
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| Secondary | Percentage of Patients With Normal Body Temperature (≤37.0ºС) | Axillary temperature (morning and evening) decline to or below 37.0 ºС | | Posted | | Number | | percentage of participants | | On day 2, 3, 4, 5 of observation | | | | ID | Title | Description |
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| OG000 | Ergoferon in Liquid Dosage Form | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | | OG001 | Placebo | Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. |
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| Secondary | 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. | | Posted | | Mean | Standard Deviation | Score | | on Days 2, 3, 4, 5 of Observation | | | | ID | Title | Description |
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| OG000 | Ergoferon in Liquid Dosage Form | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. |
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| Secondary | Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data | 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. | | Posted | | Mean | Standard Deviation | hours | | baseline and days 2, 3, 4 and 5 of observation | | | | ID | Title | Description |
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| OG000 | Ergoferon in Liquid Dosage Form | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | | OG001 | Placebo | Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. |
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| Secondary | 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. | | Posted | | Mean | Standard Deviation | AUC score*day | | On days 1-6 of observation | | | | ID | Title | Description |
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| OG000 | Ergoferon in Liquid Dosage Form | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | |
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| Secondary | Number of Intakes of Antipyretics if Indicated | Based on data mentioned in a patient's diary | | Posted | | Mean | Standard Deviation | Number of intakes | | On day 1, 2, 3, 4 and 5 of the treatment | | | | ID | Title | Description |
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| OG000 | Ergoferon in Liquid Dosage Form | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | | OG001 | Placebo | Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. |
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| Secondary | Percentage of Patients With Exacerbation of the Disease Course | The development of disease complications requiring antibiotics administration or hospitalization | | Posted | | Number | | percentage of participants | | On days 1-6 of observation | | | | ID | Title | Description |
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| OG000 | Ergoferon in Liquid Dosage Form | Children aged 3 to 18 years were on the treatment regimen with Ergoferon in Liquid Dosage Form for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. | | OG001 | Placebo | Children aged 3 to 18 years were on the treatment regimen with Placebo for 5 days. 1 dosing spoon (5 ml) per 1 intake: on day 1 of the treatment 8 dosing spoons (1 dosing spoon every 30 minutes for the first 2 hours, then 1 dosing spoon 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 dosing spoon tablet 3 times a day. |
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