Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children (NCT07171099) | Clinical Trial Compass
RecruitingPhase 3
Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children
Russia264 participantsStarted 2025-10-03
Plain-language 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.
Who can participate
Age range
6 Months – 3 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Outpatients of both genders aged over 6 months and under 3 years.
. Clinically confirmed diagnosis of acute viral upper respiratory tract infections (acute pharyngitis, nasopharyngitis, tonsillitis, laryngitis, laryngotracheitis, tracheitis, acute viral respiratory infection of multiple and unspecified localization) during the epidemic growth of influenza and ARVI.
. Dry (non-productive) cough lasting at least 24 hours but not more than 72 hours.
. Total (day and night) cough severity score of 6 or more.
. Availability of a patient information sheet and an informed consent form for participation in the clinical trial signed by one of the patient's parents/adoptive parents.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.