Trial | NCT01113346  Report issue

Title

A Pilot Study of Filtrum-STI in Children With Viral Gastroenteritis
Phase II Double Blind Placebo-controled Randomized Comparative Multicentered Study of Efficacy and Safety of Filtrum-STI, 0,4g Tablets (Produced by AVVA RUS) in Children With Viral Gastroenteritis

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    lignin hydrolytic ...

  • Study Participants

    150
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
Study Started
Jun 30
2010
Primary Completion
Dec 31
2010
Anticipated
Study Completion
Feb 28
2011
Anticipated
Last Update
Jul 14
2010
Estimate

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.

  • Other names: lignin hydrolytic, sorbent, enterosorbent

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.

Filtrum-STI Experimental

Placebo Placebo Comparator

Criteria 

Inclusion Criteria:

children aged 0-4 y.o. diagnosed with moderate viral gastroenteritis;
72 h or less from the onset of gastrointestinal symptoms.

Exclusion Criteria:

severe diseases;
individual intolerance of Filtrum-STI
treatment with antiviral, immunomodulatory drugs during the study and 2 weeks before inclusion
treatment with pre- pro- and antibiotics 2 weeks before inclusion
participation in other clinical study 1 month before inclusion and during participation in the study.
No Results Posted