Effectiveness and Safety of Benemix® in Constipation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powder.
- Who it may be relevant to
- Registry conditions: Constipation - Functional. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effectiveness and Safety of Benemix®, a Functional Food, in the Management of Constipation in Adults
Overview
The goal of this clinical trial is to find out whether the functional food Benemix® helps treat constipation in adults and whether it is safe to use. The main questions this study aims to answer are: Does Benemix® help improve bowel movement frequency and consistency in adults with constipation? What medical problems, if any, do participants experience while taking Benemix®? Adults with constipation will take Benemix® every day for 15 days. During the second week, participants will have either an in-person clinic visit or a telemedicine appointment for checkups and tests. Participants will also receive follow-up phone calls to record: * daily treatment adherence * signs and symptoms * the number of bowel movements each day.
Interventions
- Dietary supplement Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powder
Benemix® is a functional food formulation designed to support intestinal health and relieve functional constipation in adults. It contains a combination of turmeric (Curcuma longa), onion (Allium cepa), magnesium, and lactose-free skimmed milk powder. Participants will consume one oral serving of Benemix® once daily for 15 consecutive days. The product is provided as a powdered formulation that must be reconstituted in water or milk prior to consumption. Benemix® differs from other dietary int
Primary outcome measures
- Change in frequency of bowel movements [Time frame: From baseline (Day 0) to Day 15.]
- Change in stool consistency measured by the Bristol Stool Form Scale (BSFS) [Time frame: From baseline (Day 0) to Day 15.]
- Incidence of adverse events [Time frame: Throughout the 15-day intervention period.]
Eligibility criteria
Inclusion criteria
- Adults (≥18 years old) who use Benemix® for the management of constipation.
- Participants who are using the product for the first time.
Exclusion criteria
- Pregnant or breastfeeding women.
- Individuals with a diagnosis of severe gastrointestinal diseases, mental disorders, hemophilia, and/or cancer.
- Individuals who have used laxatives within the last 7 days.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07427914 · Acta Nº 285 CEI-FE (UDEA)