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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

NCT07082673 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2025-07-30

No results posted yet for this study

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.

Conditions

  • Functional Constipation (FC)

Interventions

DIETARY_SUPPLEMENT

Sea Buckthorn (Hippophae rhamnoides L.) botanical extract 500 mg.

Dietary supplement based on sea buckthorn extract (Hippophae rhamnoides L.) at a dose of 500 mg - DOSE A (1 capsule of supplement + 2 capsules of placebo).

DIETARY_SUPPLEMENT

Sea buckthorn (Hippophae rhamnoides L.) 1500 mg.

Dietary supplement based on sea buckthorn (Hippophae rhamnoides L.), at a dose of 1500 mg - DOSE B (3 capsules of supplement).

DIETARY_SUPPLEMENT

Placebo

Placebo (3 capsules of placebo).

Sponsors & Collaborators

  • ISTITUTO FARMOCHIMICO FITOTERAPICO: EPO SRL

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-24
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07082673 on ClinicalTrials.gov