The purpose of the study is to demonstrate the antidiarrheal efficacy of colloidal silicon dioxide in tablet dosage form (Carbowhite) in patients with acute diarrhea.
Background: Diarrhea is a medical condition characterized by frequent stool, more than 3 times (and more than 5-7 times in newborns) within the last 24 hours, and/or loose stool. The fecal matter is liquid, its daily mass exceeds 200 g per day, and water content reaches 95%. Objectives: To demonstrate the antidiarrheal efficacy of colloidal silicon dioxide in tablet dosage form (Carbowhite) in patients with acute diarrhea. Methods: A randomized clinical trial, double-blind, placebo-controlled, multi-center.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
145
Reduction in Frequency of Defecation to 3 Times Per Day
Percent of patients administered the investigational production who achieved the efficacy endpoint (reduction in frequency of defecation to 3 times per day, absence of loose stool) on Day 5 or earlier
Time frame: From randomisation up to 5 days
Compliance Rate
Percent of patients administered the investigational production who discontinued the study
Time frame: From randomisation up to 5 days
Duration of Treatment
Mean duration of treatment
Time frame: From randomisation up to 5 days
Quantity of Used Medication
Mean quantity of tablets per treatment course
Time frame: From randomisation up to 5 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.