NCT05345028

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 3, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

April 12, 2022

Last Update Submit

April 19, 2022

Conditions

Acute DiarrheaBoswellia Serrata

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Self-assessed symptoms

    After 5 days

  • Self-assessed symptoms

    After 5 days

Study Arms (2)

Boswellia Phytosome

ACTIVE COMPARATOR
Dietary Supplement: lecithin-based delivery form of Boswellia serrata

Placebo

PLACEBO COMPARATOR
Combination Product: Placebo

Interventions

lecithin-based delivery form of Boswellia serrataDIETARY_SUPPLEMENT

250 mg for 5 days

Boswellia Phytosome
PlaceboCOMBINATION_PRODUCT

250 mg for 5 days

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • presence of acute diarrhea of mild to moderate severity

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda di Servizi alla Persona

Pavia, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2022

First Posted

April 25, 2022

Study Start

March 3, 2021

Primary Completion

May 24, 2021

Study Completion

September 7, 2021

Last Updated

April 25, 2022

Record last verified: 2022-04

Locations

IT(1)