Actively Recruiting

Phase 3
Age: 3Years - 12Years
All Genders
NCT06715891

Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of ARVI in Children Aged 3-12 Years

Led by Materia Medica Holding · Updated on 2026-03-13

374

Participants Needed

35

Research Sites

163 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial.

CONDITIONS

Official Title

Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of ARVI in Children Aged 3-12 Years

Who Can Participate

Age: 3Years - 12Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 3 to 12 years of either gender
  • Diagnosis of ARVI with axillary temperature ≥37.8°C and symptom severity scores meeting specified thresholds
  • Symptoms started within 24 hours prior to enrollment
  • Signed informed consent obtained from parent or adopter
Not Eligible

You will not qualify if you...

  • Severe influenza or ARVI requiring hospitalization
  • Suspected bacterial infections requiring antibiotics from disease onset
  • Early signs of diseases mimicking ARVI
  • Need for antiviral medications prohibited in this trial
  • History of primary or secondary immunodeficiency
  • History or suspicion of cancer except benign tumors
  • Exacerbation or decompensation of chronic diseases affecting participation
  • Malabsorption syndromes such as lactase deficiency or galactosemia
  • Allergy to any treatment components
  • Use of prohibited medications within 2 weeks before enrollment
  • Expected non-compliance with study procedures
  • History of mental illness except ADHD in patient or parents
  • Participation in other clinical trials within 3 months
  • Parent/adopter related to research personnel or company employees involved in the trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 35 locations

1

Gatchina Clinical Interdistrict Hospital

Gatchina, Russia, 188300

Actively Recruiting

2

Kazan State Medical University/Department of Hospital Pediatrics

Kazan', Russia, 420012

Actively Recruiting

3

LLC "MedLight"

Kazan', Russia, 420097

Actively Recruiting

4

Regional Clinical Hospital # 2

Krasnodar, Russia, 350012

Actively Recruiting

5

Specialized Clinical Infectious Diseases Hospital

Krasnodar, Russia, 350015

Actively Recruiting

6

Central Research Institute of Epidemiology/Clinical Department of Infectious Pathology

Moscow, Russia, 111123

Actively Recruiting

7

Morozovskaya Children's City Clinical Hospital of the Moscow City Health Department

Moscow, Russia, 119049

Actively Recruiting

8

First Moscow State Medical University named after I.M. Sechenov/Department of Childhood Diseases

Moscow, Russia, 119991

Actively Recruiting

9

Llc "Diagnostics and Vaccines"

Moscow, Russia, 129515

Terminated

10

LLC "Health Laboratory"

Mytishchi, Russia, 141002

Not Yet Recruiting

11

Novosibirsk State Medical University/Clinic "Medical Advisory Center"

Novosibirsk, Russia, 630091

Actively Recruiting

12

Omsk State Medical University/Department of Hospital Pediatrics with a Course of Continuing Professional Education

Omsk, Russia, 644099

Actively Recruiting

13

City Children's Clinical Polyclinic # 5

Perm, Russia, 614066

Actively Recruiting

14

LLC "Professor's Clinic"

Perm, Russia, 614070

Actively Recruiting

15

LLC "4D Ultrasound Clinic"

Pyatigorsk, Russia, 357502

Actively Recruiting

16

Clinical and diagnostic center "Health"

Rostov-on-Don, Russia, 344011

Actively Recruiting

17

LLC "Eurodon Clinic"

Rostov-on-Don, Russia, 344022

Not Yet Recruiting

18

Rostov State Medical University/Department of Childhood Diseases # 2

Rostov-on-Don, Russia, 344022

Not Yet Recruiting

19

Rostov State Medical University/Department of Childhood Diseases # 3

Rostov-on-Don, Russia, 344022

Not Yet Recruiting

20

Ryazan State Medical University named after Academician I.P. Pavlov/Department of Children's Diseases with a course in hospital pediatrics

Ryazan, Russia, 390026

Actively Recruiting

21

Children's City Polyclinic # 44

Saint Petersburg, Russia, 191144

Actively Recruiting

22

Saint Petersburg State Pediatric Medical University/Department of Infectious Diseases of Adults and Epidemiology

Saint Petersburg, Russia, 194100

Actively Recruiting

23

Children's City Polyclinic # 35

Saint Petersburg, Russia, 196191

Actively Recruiting

24

City Polyclinic # 3

Saint Petersburg, Russia, 199155

Not Yet Recruiting

25

City Polyclinic # 4

Saint Petersburg, Russia, 199178

Not Yet Recruiting

26

Samara Regional Children's Clinical Hospital named after N.N. Ivanovoy/Department of Medical Rehabilitation

Samara, Russia, 443079

Actively Recruiting

27

Samara State Medical University/Department of Hospital Pediatrics

Samara, Russia, 443099

Actively Recruiting

28

National Research Mordovian State University named after N.P. Ogarev/Department of Pediatrics/

Saransk, Russia, 430005

Actively Recruiting

29

Saratov City Children's Clinical Hospital

Saratov, Russia, 410064

Actively Recruiting

30

Smolensk State Medical University/Department of Children's Diseases of the Medical and Dental Faculties

Smolensk, Russia, 214019

Actively Recruiting

31

Bashkir State Medical University/Department of Outpatient and Emergency Pediatrics

Ufa, Russia, 450008

Actively Recruiting

32

Yaroslavl State Medical University/Department of Pediatrics, Institute of Continuous Professional Education

Yaroslavl, Russia, 150000

Actively Recruiting

33

Clinical Hospital # 2

Yaroslavl, Russia, 150030

Actively Recruiting

34

Children's City Clinical Hospital # 11 Ekaterinburg

Yekaterinburg, Russia, 620028

Actively Recruiting

35

Ural State Medical University/Department of Infectious Diseases, Phthisiology and Pulmonology

Yekaterinburg, Russia, 620028

Actively Recruiting

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Research Team

M

Mikhail Putilovskiy, MD,PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of ARVI in Children Aged 3-12 Years | DecenTrialz