Acute DiarrheaNCT05345028
Boswellia Serrata Extract in Acute Diarrhea
A study testing lecithin-based delivery form of Boswellia serrata in people with Acute Diarrhea and Boswellia Serrata, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Diarrhea, Boswellia Serrata
- What is being tested?
- lecithin-based delivery form of Boswellia serrata
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteItaly
- Study dates
- 3 Mar 2021to 7 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- presence of acute diarrhea of mild to moderate severity
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acute Diarrhea, Boswellia Serrata
- Being tested
- lecithin-based delivery form of Boswellia serrata, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lecithin-based delivery form of Boswellia serrataDietary supplement
250 mg for 5 days
PlaceboCombination product
250 mg for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Boswellia Phytosome | Active comparator | Not described Receives: Dietary Supplement: lecithin-based delivery form of Boswellia serrata |
| Placebo | Placebo comparator | Not described Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stoppage of diarrhea
the occurrence of the first formed stool or a period of 12 hours without any liquid or soft stools
Measured: From baseline to 5 days
Secondary outcomes (2)
Self-assessed symptoms
daily number of stools within 5 days of treatment
Measured: After 5 days
Self-assessed symptoms
percentage of subjects without diarrhea within 5 days of treatment
Measured: After 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start3 Mar 2021
- Primary completion24 May 2021
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345028
- Sponsor's protocol ID
- 4806/11012022
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 25 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Effects of a Lecithin-based Delivery Form of Boswellia Serrata Extract in Acute Diarrhea of Adult Subjects
- ClinicalTrials.gov ID
- NCT05345028
- Acronym / sponsor ID
- 4806/11012022
- Conditions
- Acute Diarrhea, Boswellia Serrata
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 24 May 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Boswellia Phytosome | Active comparator | Dietary Supplement: lecithin-based delivery form of Boswellia serrata |
| Placebo | Placebo comparator | Combination Product: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- presence of acute diarrhea of mild to moderate severity
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lecithin-based delivery form of Boswellia serrata250 mg for 5 days | Dietary supplement | Boswellia Phytosome |
| Placebo250 mg for 5 days | Combination product | Placebo |
Primary outcome
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
2 secondary outcomes
Self-assessed symptoms
Time frame: After 5 days
Self-assessed symptoms
Time frame: After 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lecithin-based delivery form of Boswellia serrata in people with Acute Diarrhea and Boswellia Serrata, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stoppage of diarrhea (time frame: From baseline to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.