Ergoferon
DrugSafety and Efficiency of Ergoferon in treatment of Influenza
NCT Number: NCT01804946
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
Looking for future studies?
Notify Me18 year–60 year
All sexes
Interventional
Phase 4
Federal State Budgetary Institution "Polyclinic № 3" of Affairs Management Department of the President of Russian Federation, Moscow, Russia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Safety and Efficiency of Ergoferon in treatment of Influenza
Safety and Efficiency in treatment of Influenza
Other names: Tamiflu
Time frame: Day 1 to Day 5
Axillary temperature (morning and evening) decline to or below 37.0 ºС (without subsequent increase during ≥24 h)
Time frame: on the day 7 of the observation
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: Day 1 to Day 7
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: on days 1, 3 and 7 of the observation
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
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)
Time frame: Day 1 to Day 5
A subject recorded the number of antipyretic intake in patient diary.
Time frame: Day 7 vs. Day 1
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
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 1 to Day 7
Pneumonia, sinusitis, otitis media are examples of the influenza complications
Materia Medica Holding
Industry
Multicentre Open Label Comparative Parallel-group Randomized Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04794829
COVID-19, Coronaviridae Infections
Bethesda, Maryland, United States
View Trial DetailsNCT07737106
Infections, Influenza
Bayan Nur, Inner Mongolia, China
View Trial DetailsNCT06518577
Infections, Influenza
Phoenix, Arizona, United States
View Trial DetailsNCT06560151
Infections, Influenza
Atlanta, Georgia, United States
View Trial Details