Boswellia Serrata Extract in Acute Diarrhea | NCT05345028

Studies
Boswellia Serrata Extract in Acute Diarrhea

NCT05345028

Sponsor

Azienda di Servizi alla Persona di Pavia

Status

Completed

Last Update Posted

Apr 25, 2022Actual

Enrollment

49Actual

Phase

Not Applicable

Conditions

Acute Diarrhea
Boswellia Serrata

Interventions

lecithin-based delivery form of Boswellia serrata
Placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2021Actual

Primary Completion Date

May 24, 2021Actual

Completion Date

Sep 7, 2021Actual

First Submitted Date

Apr 12, 2022

First Submission Date that Met QC Criteria

Apr 19, 2022

First Posted Date

Apr 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2022

Last Update Posted Date

Apr 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Boswellia Phytosome	Active Comparator		Dietary Supplement: lecithin-based delivery form of Boswellia serrata
Placebo	Placebo Comparator		Combination Product: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lecithin-based delivery form of Boswellia serrata	Dietary Supplement	250 mg for 5 days	Boswellia Phytosome

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda di Servizi alla Persona		Pavia			Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided