Acute Diarrhea, Boswellia Serrata
Conditions
Brief summary
Acute diarrhea is a frequent problem worldwide, mostly due to gastrointestinal infections or food poisoning. Boswellia serrata could be active in the treatment of acute diarrhea due to its an-ti-inflammatory, antispasmodic and antimicrobial activity.
Interventions
DIETARY_SUPPLEMENTlecithin-based delivery form of Boswellia serrata
250 mg for 5 days
COMBINATION_PRODUCTPlacebo
250 mg for 5 days
Sponsors
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* presence of acute diarrhea of mild to moderate severity
Exclusion criteria
* patients with long term diarrhea * iatrogenic diarrhea * symptoms of functional gut disease or severe inter-current diseases * severe diarrhea and dehydration requiring hospitalization and intravenous treatment * subjects with high temperature (\> 38.5° C) * subjects treated by other anti-diarrheal and antibiotic drugs in the last 24 hours * severely malnourished subjects * pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stoppage of diarrhea | From baseline to 5 days | the occurrence of the first formed stool or a period of 12 hours without any liquid or soft stools |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-assessed symptoms | After 5 days | daily number of stools within 5 days of treatment |
Countries
Italy
Outcome results
None listed