Effectiveness and Safety of Benemix® in Constipation
ConditionConstipation - Functional
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad de Antioquia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (≥18 years old) who use Benemix® for the management of constipation.
Participants who are using the product for the first time.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powder
Dietary supplementBenemix® 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 interventions by combining bioactive compounds from turmeric and onion, which have anti-inflammatory and digestive properties, with magnesium, known for its osmotic laxative effect. The lactose-free dairy base is intended to improve tolerability in individuals who are sensitive to lactose. All participants will receive instructions on proper preparation and use of the product. Treatment adherence will be monitored through follow-up phone calls and daily symptom diaries.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Benemix Functional Food GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in frequency of bowel movements
Number of spontaneous bowel movements per week recorded using a daily patient diary. Unit of Measure: Number of bowel movements per week
Time frame
From baseline (Day 0) to Day 15.2
Change in stool consistency measured by the Bristol Stool Form Scale (BSFS)
Stool consistency will be assessed using the Bristol Stool Form Scale (BSFS), a validated 7-point scale (Type 1 = separate hard lumps; Type 7 = entirely liquid). Types 3-4 represent normal stool consistency. Lower scores indicate harder stools; higher scores indicate looser stools.
Time frame
From baseline (Day 0) to Day 15.3
Incidence of adverse events
Number and type of adverse events recorded during the 15-day intervention period, classified according to severity and relationship to the product. Number of participants with adverse events
Time frame
Throughout the 15-day intervention period.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: