Back to resultsBoswellia Serrata Extract in Acute Diarrhea
Primary Purpose
Acute Diarrhea, Boswellia Serrata
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
lecithin-based delivery form of Boswellia serrata
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Diarrhea
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
Sites / Locations
- Azienda di Servizi alla Persona
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Boswellia Phytosome
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Stoppage of diarrhea
the occurrence of the first formed stool or a period of 12 hours without any liquid or soft stools
Secondary Outcome Measures
Self-assessed symptoms
daily number of stools within 5 days of treatment
Self-assessed symptoms
percentage of subjects without diarrhea within 5 days of treatment
Full Information
NCT ID
NCT05345028
First Posted
April 12, 2022
Last Updated
April 19, 2022
Sponsor
Azienda di Servizi alla Persona di Pavia
1. Study Identification
Unique Protocol Identification Number
NCT05345028
Brief Title
Boswellia Serrata Extract in Acute Diarrhea
Official Title
Positive Effects of a Lecithin-based Delivery Form of Boswellia Serrata Extract in Acute Diarrhea of Adult Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
May 24, 2021 (Actual)
Study Completion Date
September 7, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda di Servizi alla Persona di Pavia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Diarrhea, Boswellia Serrata
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Boswellia Phytosome
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
lecithin-based delivery form of Boswellia serrata
Intervention Description
250 mg for 5 days
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
250 mg for 5 days
Primary Outcome Measure Information:
Title
Stoppage of diarrhea
Description
the occurrence of the first formed stool or a period of 12 hours without any liquid or soft stools
Time Frame
From baseline to 5 days
Secondary Outcome Measure Information:
Title
Self-assessed symptoms
Description
daily number of stools within 5 days of treatment
Time Frame
After 5 days
Title
Self-assessed symptoms
Description
percentage of subjects without diarrhea within 5 days of treatment
Time Frame
After 5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Azienda di Servizi alla Persona
City
Pavia
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Boswellia Serrata Extract in Acute Diarrhea
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