Clinical Trial

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

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated July 30, 2025 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-23.
Status change: Not Yet Recruiting → Recruiting 2025-07-25
Trial Details
NCT Number NCT07082673
Lead Sponsor ISTITUTO FARMOCHIMICO FITOTERAPICO: EPO SRL
Conditions Functional Constipation (FC)
Enrollment 135 participants
Start Date 2025-07-24
Primary Completion 2025-09 (estimated)
Study Completion 2025-09 (estimated)
Updated on ClinicalTrials.gov 2025-07-30