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Efficacy and Safety of Rengalin in the Treatment of ARVI Cough in Children

NCT07171099 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2026-02-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Rengalin

Solution for oral administration

DRUG

Placebo

Solution for oral administration

Sponsors & Collaborators

  • Materia Medica Holding

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-03
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07171099 on ClinicalTrials.gov