Study to Evaluate the Efficacy of Arrae's Bloat & Calm Alchemy Capsules to Reduce Bloating, Heartburn and Gas, and Alleviate the Intensity of IBS Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Reduction in anxiety symptoms
研究概览
简要总结
This is an open-label observational crossover trial to study the efficacy of a commercial dietary supplement and its effect on common symptoms of IBS (such as bloating, gas, heartburn, and other symptoms).
详细描述
It is hypothesized that the dietary supplement marketed as "Arrae Bloat" will improve subjective wellbeing in trial participants. It is further hypothesized that a second dietary supplement marketed as "Arrae Calm" will support the effects of "Arrae Bloat", while reducing stress, anxiety and panic and promoting restful sleep and easing tension in the body, which has previously been reported in customer feedback studies.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female over 18 years old
- •Self-reported (undiagnosed) IBS symptoms, such as self-reported abdominal pain, gas production and bloating after meals, heartburn after meals
- •Must be in good health (don't report any medical conditions asked in the screening questionnaire)
- •Following a stable, consistent diet regimen
- •Agree to refrain from any lifestyle changes that may affect their GI tract and IBS symptoms for the duration of the study
- •May have self-reported sleep issues
- •May have self-reported mild anxiety/depression
- •May have self-reported occasional panic attacks
排除标准
- •Prior prescriptions for IBS
- •Current IBS treatment (e.g. proton pump inhibitors, laxatives)
- •Follow an extreme diet intervention
- •Experienced severe weight loss in the past 3 months prior to study participation
- •Antibiotic usage within 3 months prior of study participation
- •Usage any medication or herbal remedies which can affect the GI tract
- •Food intolerances/allergies
- •Pineapple sensitivity/allergy
- •Taking cortisol lowering prescription medication
- •Has any of the following medical conditions:
- •History of GI tract cancers Celiac disease / gluten intolerance GI bleeding Rectal bleeding Heme-positive stool Iron-deficiency anemia Systemic signs of infection Insomnia Moderate to severe depression/anxiety Moderate to severe panic attacks
- •Females that are pregnant, want to become pregnant for the duration of the study, or who are breastfeeding
结局指标
主要结局
Reduction in anxiety symptoms
时间窗: 8 weeks
Survey-based assessment (0-5 scale with 0 being the lowest possible score and 5 being the highest) of changes in anxiety symptoms between baseline and study intervention period.
Reduction in IBS symptoms (bloating, heartburn and gas)
时间窗: 4 weeks
Survey-based assessment (0-5 scale with 0 being the lowest possible score and 5 being the highest) of changes in IBS symptoms between baseline and study intervention period.
次要结局
未报告次要终点