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