Mytishchi

Researchers are conducting a multicenter, double-blind, placebo-controlled, randomized clinical trial to study children aged 3 to 12 years with acute respiratory viral infection (ARVI) symptoms within 24 hours of onset. The trial aims to evaluate the efficacy and safety of Raphamin compared to a placebo in treating ARVI. Enrollment will begin with children aged 6 to 12 years, followed by an interim analysis to decide whether to include younger children aged 3 to 5 years. Patients will be outpatients of either gender during seasonal ARVI incidence. Participants will be randomly assigned to receive either Raphamin tablets or placebo tablets for 5 days. Treatment groups follow the same dosage regimen. Before starting therapy, nasopharyngeal swabs will confirm viral infection through PCR testing. Throughout the trial, an electronic patient diary will be used to record temperature, symptoms, antipyretic use, and any worsening condition. The study includes screening, randomization, treatment, and follow-up periods lasting a total of 14 days. During the study, patients will attend three visits on days 1, 5, and 7, either at a health center or home, plus a phone visit on day 14. At visits, physicians will assess symptom severity, perform examinations, monitor diary completion, and conduct lab tests. The main outcome measured is the time needed for ARVI symptoms to resolve within 14 days. Safety and compliance will be closely monitored, and symptomatic or concomitant therapies are allowed except for prohibited drugs.

Researchers are evaluating the efficacy and safety of a liquid form of Rengalin for treating cough in children aged 6 months to 3 years who have acute viral upper respiratory infections during flu and ARVI outbreaks. This Phase 3 clinical trial compares Rengalin with a placebo to see if it effectively reduces cough severity in young children with dry or non-productive cough lasting between 24 and 72 hours. Participants will be randomly assigned to receive either Rengalin or a placebo, both given orally as 5 ml doses three times a day for 7 days. The study includes several visits: at the start (Day 1), at Day 4 for evaluation and potential addition of mucolytic therapy if needed, and at Day 8 for further assessment and sample collection. Parents will use an electronic diary to record their child's cough severity twice daily throughout the treatment period. During the study, doctors will monitor the child's condition, check for complications, and assess safety through physical exams, laboratory tests, and questionnaires. Follow-up continues up to 14 days, including a phone interview to evaluate recovery and any complications. The main result measured is the percentage of children who respond to the treatment by Day 3 compared to their baseline cough severity.