Boswellia Serrata Extract in Acute Diarrhea

Acute Diarrhea Clinical Trial

Official title:

Positive Effects of a Lecithin-based Delivery Form of Boswellia Serrata Extract in Acute Diarrhea of Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05345028
• Other study ID #: 4806/11012022
• Status: Completed
• Phase: N/A
• Start date: March 3, 2021
• Est. completion date: September 7, 2021

Study information

• Verified date: April 2022
• Source: Azienda di Servizi alla Persona di Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 7, 2021
• Est. primary completion date: May 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Diarrhea
• Diarrhea

Intervention

Dietary Supplement:
• lecithin-based delivery form of Boswellia serrata
250 mg for 5 days

Combination Product:
• Placebo
250 mg for 5 days

Locations

Country	Name	City	State
Italy	Azienda di Servizi alla Persona	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda di Servizi alla Persona di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stoppage of diarrhea	the occurrence of the first formed stool or a period of 12 hours without any liquid or soft stools	From baseline to 5 days
Secondary	Self-assessed symptoms	daily number of stools within 5 days of treatment	After 5 days
Secondary	Self-assessed symptoms	percentage of subjects without diarrhea within 5 days of treatment	After 5 days