Efficacy and Tolerability of Sea Buckthorn Extract at Two Doses for Managing Bowel Function in Primary Functional Constipation: Randomized, Placebo-controlled, Double-blind Trial

What this Trial Is About

Researchers are evaluating the effects of a food supplement made from sea buckthorn extract (Hippophae rhamnoides L.) for adults aged 18 to 70 who have primary functional constipation. The study aims to determine how well this supplement improves bowel movement frequency and tolerability. It also looks at changes in stool consistency and reduction in constipation symptoms like bloating, abdominal pain, and flatulence, which affect quality of life. Participants will be randomly assigned to one of three groups: one taking a low dose of sea buckthorn supplement (500 mg), another taking a higher dose (1500 mg), and the last receiving a placebo. The study is double-blind, so neither the participants nor the researchers will know who receives which treatment. The treatment period lasts 28 days, during which all participants will take three capsules daily according to their assigned group. During the study, participants will be monitored closely with assessments of bowel movements, stool consistency using the Bristol Stool Form Scale, and symptoms recorded in a bowel function diary. Quality of life related to constipation will also be evaluated. Safety monitoring includes tracking any adverse reactions, with special attention to women of childbearing age who must use contraception and will be excluded if pregnant. The total participation time covers screening, 28 days of treatment, and follow-up at a single clinical site.

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