Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children
brief summary
The goal of this clinical trial is to evaluate the efficacy and safety of liquid dosage form of Rengalin in the treatment of cough in acute viral upper respiratory tract infections infections in children in during the epidemic growth of influenza and ARVI. The main questions it aims to answer are: Investigators will compare the liquid dosage form of Rengalin to a placebo (a look-alike substance that contains no drug) to see if Rengalin in the liquid dosage form works for cough in acute viral upper respiratory tract infections in children. Participants will: Take the liquid dosage form of Rengalin or placebo per os 5 ml per administration 3 times a day for 7 days.
detailed description
The design is a multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial evaluating the efficacy and safety of the study therapy.
The trial will enroll children of either gender aged 6 months to 3 years, who consulted a physician for dry/non-productive cough caused by acute viral upper respiratory tract infections during the seasonal growth of influenza and ARVI.
The duration of cough at inclusion in the trial should be at least 24 hours but not more than 72 hours; cough severity - 6 or more points (according to the Cough Severity Score (CSS)).
After one of the parents/adoptive parents signs the patient information leaflet (PIL) and the informed consent form (ICF) (two versions are used - with the consent of the parent/adoptive parent to take blood and urine samples for the purpose of conducting laboratory tests or without consent) for participation in the clinical trial at Visit 1, complaints and anamnesis are collected, vital signs are assessed, a physical examination is performed, concomitant therapy is recorded, and laboratory tests are conducted.
It is planned to conduct a general urine analysis, general and biochemical blood tests in at least 50% of patients.
At Visit 1, the physician together with the parent/adoptive parent fills out the CSS scale.
If inclusion criteria are met and there are no any exclusion criteria at Visit 1 (Day 1), the patient is enrolled in the study and randomized to one of two groups: Group 1 patients will receive Rengalin; Group 2 patients will receive Placebo.
After three days of the study therapy, at Visit 2 (Day 4), the physician evaluates the patient's condition and adjusts the therapy. If there are indications (secretion of viscous sputum), the physician prescribes the mucolytic ambroxol; at the same time, patients of group 1 continue taking Rengalin, and patients of group 2 continue taking Placebo.
The study will use an electronic patient diary (EPD) in which the parent/adoptive parent will record the severity of daytime and nighttime cough as measured by the CSS during the 7 days the patient is in the study. In addition, any possible worsening of the patient's condition (if applicable) will be recorded in the EPD for safety assessment and recording of adverse events.The investigator will instruct parents/adoptive parents will instruct parents/adoptive parents on how to fill out the diary.
official title
Multicenter, Double-blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Rengalin in the Treatment of Cough in Acute Viral Upper Respiratory Tract Infections Tract Infections in Children During the Epidemic Growth of Influenza and ARVI