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. This trial aims to evaluate the safety and effectiveness of Raphamin in treating ARVI symptoms during the seasonal incidence of the illness. Enrollment starts with children aged 6 to 12 years and may expand to include those aged 3 to 12 years based on interim safety and efficacy results. Participants will be randomly assigned to receive either Raphamin or a placebo. Raphamin is given orally as tablets that dissolve in the mouth, with a specific dosing schedule over five days eight tablets on the first day taken at intervals, then one tablet three times daily on days two through five. The placebo group follows the same dosing regimen using placebo tablets. The treatment period lasts five days, followed by monitoring and follow-up visits. During the study, parents or caregivers will record their childs symptoms and body temperature twice daily in an electronic diary, including any use of fever-reducing medications and changes in health. Children will have several visits with healthcare providers on days 1, 5, and 7, plus a phone visit on day 14 for safety and symptom assessment. Laboratory tests and physical exams will be conducted to monitor progress and safety. The primary outcome is the time until ARVI symptoms resolve within 14 days.

Researchers are evaluating the efficacy and safety of a liquid form of Rengalin for treating cough caused by acute viral upper respiratory tract infections in children aged 6 months to 3 years during the epidemic growth of influenza and ARVI. This randomized, double-blind, placebo-controlled trial compares Rengalin with a placebo to determine its effect on cough severity in young children. Participants will be randomly assigned to receive either 5 ml of Rengalin or a placebo orally three times a day for 7 days. The study includes initial screening and consent, followed by treatment and monitoring visits on days 1, 4, and 8, with a phone follow-up on day 14. On day 4, if needed, mucolytic ambroxol may be added while continuing the assigned study treatment. Parents will use an electronic diary to record cough severity twice daily throughout the study. During the study, researchers will assess symptoms, perform physical exams, and conduct laboratory tests including blood and urine analyses in at least half the participants. Safety and treatment adherence are closely monitored through visits and diaries. The main outcome is the percentage of patients responding to treatment by day 3, with secondary outcomes including changes in cough severity by day 7. The total study duration for participants is up to 14 days with ongoing observation.