Boswellia Serrata Extract in Acute Diarrhea

April 19, 2022 updated by: Azienda di Servizi alla Persona di Pavia

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy
        • Azienda di Servizi alla Persona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Combination product: Placebo
250 mg for 5 days
Active Comparator: Boswellia Phytosome
Dietary supplement: lecithin-based delivery form of Boswellia serrata
250 mg for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stoppage of diarrhea
Time Frame: From baseline to 5 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-assessed symptoms
Time Frame: After 5 days
daily number of stools within 5 days of treatment
After 5 days
Self-assessed symptoms
Time Frame: After 5 days
percentage of subjects without diarrhea within 5 days of treatment
After 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda di Servizi alla Persona di Pavia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2021

Primary Completion (Actual)

May 24, 2021

Study Completion (Actual)

September 7, 2021

Study Registration Dates

First Submitted

April 12, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4806/11012022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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