Evaluation of the Effectiveness and Safety of Benemix®, a Functional Food, in the Management of Constipation in Adults
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Change in frequency of bowel movements
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18 years old) who use Benemix® for the management of constipation.
- •Participants who are using the product for the first time.
排除标准
- •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.
研究组 & 干预措施
Benemix Functional Food Group
Participants in this arm will receive Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powder, administered orally once daily for 15 days.
干预措施: Benemix®, a functional food composed of turmeric, onion, magnesium, and lactose-free, skimmed milk powder (Dietary Supplement)
结局指标
主要结局
Change in frequency of bowel movements
时间窗: From baseline (Day 0) to Day 15.
Number of spontaneous bowel movements per week recorded using a daily patient diary. Unit of Measure: Number of bowel movements per week
Change in stool consistency measured by the Bristol Stool Form Scale (BSFS)
时间窗: From baseline (Day 0) to Day 15.
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.
Incidence of adverse events
时间窗: Throughout the 15-day intervention period.
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
次要结局
未报告次要终点
研究者
Javier Mauricio Ceballos Rueda
Pharmaceutical Chemestry
Universidad de Antioquia