Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea

• Status: Completed
• Trial end date: 2016-10-07
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Omnifarma Kiev LLC
• Treatments: Silicon

Criteria

Inclusion Criteria:

• signed Informed Consent Form for patient's study participation

• male and female patients at the ages from 18 to 55 years

• acute diarrhea (more than three episodes of liquid stool a day) within 48 hours or less in patients with usually normal stool

• body temperature of ≤ 38 °C

• patient's ability to adequately cooperate in the process of study

Exclusion Criteria:

• aged of <18 or >55 years;

• blood or pus in stool;

• body temperature of >38 °C;

• episodes of acute diarrhea for the last 30 days;

• administration of antidiarrheal products for the last 24 hours;

• salmonellosis (Salmonella of any serotype different from S. typhi and S. paratyphi; ICD-10: A02.0), dysentery (Shigella dysenteriae, Shigella flexneri, Shigella boydii; ICD-10: A03.0-A03.3), colibacillosis (Escherichia coli; ICD-10: A04.0-A04.4) which require administration of antimicrobial products;

• pregnancy, lactation;

• concomitant decompensated diseases or acute conditions which, according to an investigator, may affect study results

• alcoholism and drug abuse;

• participation in any other clinical study.