Evaluation of the Impact of the HLNatural, Inc. Upset Stomach Relief Product on the Reduction of Symptoms in Adults Who Suffer From Mild to Moderate Indigestion and Heartburn
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 1
- 主要终点
- Outcomes of the severity and reduction of indigestion while consuming HLNatural Supplement.
研究概览
简要总结
The primary hypothesis of the present study is that supplementation with the Upset Stomach Relief test product will reduce the severity of the symptoms of occasional indigestion and heartburn.
详细描述
The purpose of the present study is to evaluate 1) the impact of the test product on symptoms of occasional indigestion and heartburn in 200 adult participants who suffer from occasional indigestion and heartburn and 2) the subjective experience of these participants related to general health, indigestion and heartburn symptoms, and personal experience with the test product.
While dietary and lifestyle changes can ease the symptoms of indigestion and heartburn, HLNatural, Inc. created the test product to reduce occasional indigestion and heartburn. The test product is a plant-based remedy formulated with ingredients that have demonstrated efficacy reducing symptoms associated with occasional indigestion and heartburn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Adult candidates who are in overall good health but who suffer from the symptoms of indigestion.
- •Participants will be deemed to be in good health if they do not report any of the existing medical conditions asked about in the screening questionnaire.
排除标准
- •Age <18 years old.
- •Unwilling to take test product for their symptoms.
- •Are not able to swallow pills.
- •Allergy to any of the following: Licorice, Artichoke Leaf, Marshmallow Root, Ginger, Chamomile, Cellulose Capsule, Rice Hull Concentrate, Carrageenan.
- •Has any of the following medical conditions:
- •Has had an ulcer
- •Has been diagnosed with a digestive disorder
- •Diagnosed with gastroesophageal reflux disorder
- •Participants with diagnosed with irritable bowel syndrome
- •Participants with active HP infection or with gastric or duodenal ulcer
- •Participants who have been prescribed any medication by their physician for any GI disorder or medication that can affect the GI system.
- •Participants with previous diagnosis of cancer or with previous surgery of the upper gastrointestinal tract or of the biliopancreatic system (except for cholecystectomy)
- •Pregnant women or breastfeeding.
- •Alcohol consumption more than 7 drinks per week or more than 3 drinks per occasion
- •Participant who scores a 0, 3, or 4 on the Dyspepsia Symptom Severity Index
- •Participants who are currently using anticoagulation medications daily. (Aspirin, Coumadin, Heparin etc.)
结局指标
主要结局
Outcomes of the severity and reduction of indigestion while consuming HLNatural Supplement.
时间窗: The improvements in symptoms will be evaluated from baseline.
Participants will be asked to rate each symptom (bloating, early fullness during a meal, pain or discomfort in the upper abdomen, burning in the upper abdomen, pain/burning in the center of your chest, nausea, vomiting, and burping) on a 4-point scale at 4 time points. • At the onset of the indigestion and heartburn episode, the participant will start a Symptom Diary and complete a 4-point Likert scale for each of the symptoms they are experiencing.
次要结局
- Outcome of subjects natural behavior during the clinical trial(The time point will be evaluated from baseline to thoughout the trial up 60 days or 3 episodes of indigestion.)
- Outcomes of time to relief or to alternative treatment while taking HLNatural Supplement(The subject will write down symptoms in a diary and start of symptoms and again at 60 mins. The subject ill complete 4-point Likert Scale at start of event, 15 minutes, 30 minutes and 60 minutes after start of event.)
- Outcomes of all adverse events while consuming HLNatural Supplement(All adverse events will be captured throughout the trial which will be up to 60 days or 3 episodes of indigestion.)