A Phase 3 interventional study of Rengalin and Placebo in Cough, sponsored by Materia Medica Holding. Recruiting at 30 sites in Russia. Open to participants aged 6 Months to 3 Years. Per ClinicalTrials.gov, last updated 2026-02-13.
Sponsored by Materia Medica Holding · Phase 3, Interventional, and Treatment
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.
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.
The parent/adoptive parent will make the first marks on the cough severity scale in the EDS together with the physician at Visit 1. The EPD will be available for completion throughout the patient's participation in the study. Twice a day, the parent/adoptive parent will receive an SMS reminder: "Please mark the severity of daytime and nighttime cough in the diary. Do not forget to take the medication given to you." The patient treatment continues for 7 days, observation - for 14 days (screening, randomization - 1 day, treatment - 7 days, follow-up - up to 14 days; delayed "phone visit" - 14 days).
On days 4 (Visit 2) and 8 (Visit 3), two visits are planned (at home or at a medical center), during which the physician collects complaints, records medical examination data, identifies possible bacterial complications of acute respiratory infections, monitors prescribed and concomitant therapy, evaluates the safety of the treatment, and checks the filling of the CSS in the EPD.
At Visit 3 (Day 8), samples are collected for laboratory testing. The study drug that the parent/adopter received at Visit 1 must be returned at Visit 3 to assess compliance with the study therapy.
If the patient's condition worsens, the doctor make an unscheduled visit. "Telephone visit" (Visit 4, Day 14±1) is conducted to interview parents/adoptive parents about the patient's condition, presence/absence of cough, bacterial complications of acute respiratory viral infections, and the possible use of antibacterial drugs.
During the study, the use of antiviral drugs, symptomatic agents, and drugs for the treatment of concomitant diseases is permitted, with the exception of drugs listed in the section "Prohibited concomitant therapy".
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's planned enrollment of 264 is above the median of 80 across 319 interventional studies indexed under Cough.
Browse Cough studies →Materia Medica Holding is the lead sponsor of 43 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 drip syndrome. 1.5 Gastroesophageal reflux. 1.6 Bronchial asthma. 1.7 Cystic fibrosis. 1.8 Primary ciliary dyskinesia 1.9 Bronchopulmonary dysplasia 1.10 Malformations of the respiratory and ENT organs 1.11 Other chronic lung diseases. 1.12 Primary/secondary immunodeficiency. 1.13 Oncological disease of any localization.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Orally. 5 ml per dose 3 times a day for 7 days. The drug is taken without meals.
Drug: Rengalin
Placebo using the dosing regimen Rengalin for 7 days.
Drug: Placebo
Solution for oral administration
Solution for oral administration
The percentage of patients responded to treatment
The percentage of patients responded to treatment (reduction in the total (day and night) cough severity score to 3 points or less after 3 days of treatment - isolated cough episodes or complete absence of cough during the day) after 3 days.
Time frame: On baseline and 3 day
Change in the total CSS
Change in the total Cough Severity Score (daytime and nighttime) after 7 days of treatment compared to baseline. The minimum value - 0 (no cough) and maximum value - 10 (severe cough).
Time frame: On baseline and 7 day
Percentage of patients without daytime cough
Percentage of patients with no daytime cough acording to Cough Severity Score (SCC) after 7 days of treatment. The minimum value - 0 (no cough) and maximum value - 5 (severe cough).
Time frame: On baseline and 7 day
Percentage of patients with a decrease in daytime cough
Percentage of patients with a decrease in daytime cough severity ≤ 1 point on the Cough Severity Score (SCC) after 7 days of treatment. The minimum value - 0 (no cough) and maximum value - 5 (severe cough).
Time frame: On baseline and 7 day
Percentage of patients without night cough
Percentage of patients with no night cough (0 points according to the Cough Severity Score (SCC)) after 7 days of treatment. The minimum value - 0 (no cough) and maximum value - 5 (severe cough).
Time frame: On baseline and 7 day
Percentage of patients with a reduction in nighttime cough
Percentage of patients with a reduction in nighttime cough severity ≤ 1 point on the Cough Severity Score (SCC) after 7 days of treatment. The minimum value - 0 (no cough) and maximum value - 5 (severe cough).
Time frame: On baseline and 7 day
Cough severity
Cough severity during 7 days of treatment (based on the area under the curve (AUC) of daytime and nighttime cough scores). The area under the curve is determined in conventional units (points multiplied by days).
Time frame: 7 days
Percentage of patients prescribed the ambroxol
Percentage of patients who were additionally prescribed the mucolytic ambroxol on the 4th day of treatment.
Time frame: On 4 day
Proportion of patients required antibacterial drugs or hospitalization
Proportion of patients with worsening ARVI course (bacterial complications of ARVI that required antibacterial drugs or hospitalization) within 14 days of participation in the trial.
Time frame: 14 days of treatment
Number of patients with adverse events (AEs)
The presence of adverse events. Based on medical records.
Time frame: From day 1 to day 14
Severity of AEs
Number of patients with the intensity (severity) of adverse events. Based on medical records.
Time frame: From day 1 to day 14
Causal relationship of AEs to the sudy drug
The causal relationship to the study drug of adverse events. Based on medical records. The assessment of causality is made by the investigator based on his/her clinical opinion (certain, probable, doubtful, conditional, unclassifiable, not related).
Time frame: From day 1 to day 14
Outcome of AEs
The outcome of adverse events. Based on medical records. The outcome of AE is made by investigator (recovery/resolution, incomplete recovery/resolution, no recovery/resolution, recovery/resolution with consequences, death, unknown).
Time frame: From day 1 to day 14
Percentage of patients with clinically significant abnormal laboratory tests
Percentage of patients with clinically significant abnormal laboratory tests. Measure is based on the Hematology, blood chemistry, and urinalysis parameters, which are beyond the reference values at the end of treatment.
Time frame: On 1 and 14 days of treatment
Changes in Vital Signs (Heart Rate)
Pulse Rate measured in beats per minute. Based on medical records.
Time frame: On Visit 1 (day 1), Visit 2 (day 4) and Visit 3 (day 8)
Changes in Vital Signs (Breathing Rate)
Respiratory Rate measured in breaths per minute. Based on medical records.
Time frame: On Visit 1 (day 1), Visit 2 (day 4) and Visit 3 (day 8)
Changes in Vital Signs (Axillary temperature)
Temperature is measured in the armpit using a classic mercury-free thermometer. Based on medical records.
Time frame: On Visit 1 (day 1), Visit 2 (day 4) and Visit 3 (day 8)
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Started Oct 2025 (actual). Primary completion is estimated for Dec 2028, 38 months after the start.
Of 18 phase 3 interventional studies under Cough, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 37. This study's planned 38 months is above that.
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