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Oral Administration of Tannins and Flavonoids in Children With Acute Diarrhea

NCT03356327 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-11-29

No results posted yet for this study

Summary

A pilot, randomized, case-controlled trial was conducted in 60 children affected by AG (\< 7 days) with mild-moderate dehydration, according to WHO recommendations, from1 year to 17 years old. Patients were divided into 2 Groups: Group 1 consisting of 30 children treated with Actitan F and standard oral rehydration (SOR); Group 2 consisting of 30 children who received only SOR. Both groups received treatment for seven days, respectively. Patients of Group 1 stopped for their own choice, SOR after the first 24 h and continued only with Actitan F.

Conditions

  • Acute Diarrhea

Interventions

DRUG

Actitan F

A molecolar complex of Tannins and Flavonoids used for acute diarrhea in children

DRUG

Standard Oral Rehydration

Standard oral rehydration as suggested by ESPGHAN guidelines

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2017-07-31
Completion
2017-11-01

Countries

  • Italy

Study Locations

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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 NCT03356327 on ClinicalTrials.gov