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The Beneficial Effect on the Bowel Function of a Food Supplement Based on Sea Buckthorn (Hippophae Rhamnoides L.) Extract in Subjects With Primary Functional Constipation

RecruitingNAAges 18 Years - 70 YearsAllISTITUTO FARMOCHIMICO FITOTERAPICO: EPO SRL
NCT07082673 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The study will aim to evaluate the efficacy and tolerability of a supplementation with Sea Buckthorn (Hippophae rhamnoides L.) at two different dosages for the management of the balance of intestinal function in subjects with primary functional constipation. The primary outcome is the improvement of the frequency of bowel movements (SCBM) in subjects with functional constipation; then the secondary outcomes are the 1) improvement in stool consistency, assessed through the Bristol Stool Form Scale (BSFS) and 2) reduction in the typical symptoms of constipation, such as feeling of bloating and abdominal distension, feeling of heaviness, abdominal pain and flatulence, improving the quality of life of the subjects affected by primary functional constipation.

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📋 Eligibility rules (as published)
Inclusion Criteria: * aged between 18 and 70 years * able to understand and sign informed consent * HIV negative test * negative pregnancy test * with symptoms of chronic constipation for at least 3 months (with onset at least 6 months earlier) * absent/non-predominant abdominal pain that occurs less than one day per week and, therefore, not affected by IBS-C * who have less than three SCBWs per week and at least one of the following conditions: * in more than 25%\* of defecatory acts * lumpy or hard stools (BSFS type 1 or 2) in more than 25% of bowel movements * feeling of incomplete evacuation in more than 25% of defecations * feeling of anorectal obstruction/blockage in more than 25% of defecations * carry out manual manoeuvres to facilitate evacuation in more than 25% of defecations * able to understand and comply with the requirements of the protocol Exclusion Criteria: * pregnancy * lactation * HIV positive * do not meet inclusion criteria.
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What it tests

  • Sea Buckthorn (Hippophae rhamnoides L.) botanical extract 500 mg.
  • Sea buckthorn (Hippophae rhamnoides L.) 1500 mg.
  • Placebo
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Where

1 site
COMEGEN Soc. Coop. Sociale
Naples, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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