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A Pilot Study of Filtrum-STI in Children With Viral Gastroenteritis

NCT01113346 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2010-07-14

No results posted yet for this study

Summary

This is a phase II double blind multicenter randomized placebo-controled clinical study aimed to find out whether treatment with Filtrum-STI (orally administered 0,4g tablets) is safe and effective in children with viral gastroenteritis. Filtrum-STI (lignin hydrolytic) is a drug with a high absorbing ability, that binds and eliminates toxins, pathogenic microorganisms and viruses. Filtrum-STI is inoffensive for mucous membranes, enhances colonic propulsion and improves its natural microflora. The drug is not toxic and well combines with other medication

Conditions

  • Viral Gastroenteritis

Interventions

DRUG

Filtrum-STI (lignin hydrolytic)

For children aged less than 1 y.o.: Filtrum-STI, 400mg per day (1/2 tablet 2 times a day) for 7 days. For children aged 1-4 y.o.: Filtrum-STI, 800mg per day (1 tablet 2 times a day) for 7 days.

DRUG

Placebo

For children aged less than 1 y.o.: Placebo, 1/2 tablet 2 times a day for 7 days. For children aged 1-4 y.o.: Placebo, 1 tablet 2 times a day for 7 days.

Sponsors & Collaborators

  • St. Vladimir Moscow Children's Clinical Hospital

    collaborator UNKNOWN

  • Arhangelsk Regional Children's Clinical Hospital named after Vizshletsov P.G.

    collaborator UNKNOWN

  • Avva Rus, JSC

    lead INDUSTRY

Principal Investigators

  • Elena Meskina, MD, DrSc · St. Vladimir Children's Moscow Clinical Hospital

  • Lyudmila Kobeleva, MD, PhD · Avva Rus, JSC

  • Nickolay A. Kryuchkov, MD, PhD, MPH · Avva Rus, JSC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2010-12-31
Completion
2011-02-28

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

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 NCT01113346 on ClinicalTrials.gov