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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorISTITUTO FARMOCHIMICO FITOTERAPICO: EPO SRL

About this trial

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.

Eligibility criteria

Qualifiers

aged between 18 and 70 years

able to understand and sign informed consent

HIV negative test

negative pregnancy test

Disqualifiers

pregnancy

lactation

HIV positive

do not meet inclusion criteria.

Trial design

Treatments tested in this trial

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

Treatment groups

135 Participants
are divided into 3 treatment groups