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Tests treatment safety and results for Cough
Official title Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children
ClinicalTrials.gov ID: NCT07171099
What this study is testing
What is Rengalin?
Rengalin is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for cough.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 3
You may be able to join if
- 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...
- 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...
You likely can't join if
- Presence of the following diseases at the time of inclusion in the clinical trial: 1.1 Inflammatory processes in the lower respiratory tract. 1.2...
- Suspected bacterial infection of any localization, including pneumonia, sinusitis, otitis media.
- Allergic rhinitis.
- Bronchial obstruction syndrome.
- Acute obstructive laryngitis [croup] and epiglottitis.
- Congenital heart defects with hypervolemia in pulmonary circulation.
See the full eligibility 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...
- 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.
- Presence of the following diseases at the time of inclusion in the clinical trial: 1.1 Inflammatory processes in the lower respiratory tract. 1.2 Grade III adenoid hypertrophy. 1.3 Chronic adenoiditis. 1.4 Postnasal...
- Suspected bacterial infection of any localization, including pneumonia, sinusitis, otitis media.
- Allergic rhinitis.
- Bronchial obstruction syndrome.
- Acute obstructive laryngitis [croup] and epiglottitis.
- Congenital heart defects with hypervolemia in pulmonary circulation.
- Acute respiratory failure.
- Inflammatory, degenerative, demyelinating diseases of the central nervous system, polyneuropathies, epilepsy.
- Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in a clinical trial.
- Presence of allergy/hypersensitivity to any components of the medicines used in the treatment.
- Taking medications listed in the section "Prohibited Concomitant Therapy" within 4 weeks prior to inclusion in the study.
- Patients whose parents/adoptive parents, from the investigator's point of view, will not comply with observation requirements during the study or with the administration of study drugs.
- Participation in other clinical trials within 3 months prior to inclusion in this trial.
- A patient's parent/adoptive parent is related to on-site research personnel directly involved in the trial, or is the immediate family member of the investigator. 'Immediate family members' mean spouses, parents...
- The patient's parent/adoptive parent is employed by OOO "NPF "MATERIA MEDICA HOLDING", i.e., is an employee of the company, a temporary contract employee, or a designated official responsible for conducting the trial or...
The study team makes the final eligibility decision.
Where it's taking place
- Gatchina, Russia
- Kazan', Russia
- Krasnodar, Russia
- Moscow, Russia
- Mytishchi, Russia
- Omsk, Russia
- Perm, Russia
- Rostov-on-Don, Russia
- Ryazan, Russia
- Saint Petersburg, Russia
- Samara, Russia
- Saransk, Russia
- Saratov, Russia
- Ufa, Russia
- Yaroslavl, Russia
- Yekaterinburg, Russia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 3 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gatchina, Russia; Kazan', Russia; Krasnodar, Russia; Moscow, Russia; Mytishchi, Russia; Omsk, Russia and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.