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OpenTrials
Completed

NCT Number: NCT05345028

Boswellia Serrata Extract in Acute Diarrhea

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.

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Key information

Conditions

Acute Diarrhea Boswellia Serrata

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Azienda di Servizi alla Persona

Pavia, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lecithin-based delivery form of Boswellia serrata

Dietary Supplement

250 mg for 5 days

Placebo

Combination Product

250 mg for 5 days

Primary outcomes

  1. 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

Secondary outcomes

  1. Self-assessed symptoms

    Time frame: After 5 days

    daily number of stools within 5 days of treatment

  2. Self-assessed symptoms

    Time frame: After 5 days

    percentage of subjects without diarrhea within 5 days of treatment

Sponsors and collaborators

Lead sponsor

Azienda di Servizi alla Persona di Pavia

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 25, 2022
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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