A double-blind randomized placebo controlled Clinical study to evaluate the effectiveness and safety of Formulation HB01 for instant relief from heartburn.
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- Nutrin GmbH
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in SGA self-evaluation score
研究概览
简要总结
Heartburn is a burning pain in your chest, just behind your breastbone. The pain is often worse after eating, in the evening, or when lying down or bending over. Occasional heartburn is common and no cause for alarm. Most people can manage the discomfort of heartburn on their own with lifestyle changes and nonprescription medications. Heartburn that is more frequent or interferes with your daily routine may be a symptom of a more serious condition that requires medical care. The majority of medical professionals concur that lower esophageal dysfunction is caused by the reflux of stomach or duodenal contents into the oesophagus. It could be regarded as a functional disorder if there isn’t a visible hiatus hernia or esophagitis. Globus has also been described as being indicative of an esophageal functioning abnormality. When unrelated to dyspepsia, this sensation of having a "lump in the throat" is thought to be caused by the upper esophageal sphincter malfunctioning. Additionally, holding back tears is thought to be a physical example of suppressed emotion. Although a lot of money and time is spent treating the symptoms of these two esophageal disorders, little is known about their prevalence, how they relate to one another, or how they differ from other functional gastrointestinal disorders
Screeningand Assigning: Day 0
SubjectAssessment: Day 1
Follow-up:Day 2 for any adverse event
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
入选标准
- •1.Gender: Non-pregnant, non-lactating female aged between 18 to
- •2.Subject willing to give written informed consent 3.Women of child bearing potential must have a negative urine pregnancy test.
- •4.Free of any Kidney and Heart disorder, which in the opinion of the investigator, will interface with the study results or increase the risk of AE.
排除标准
- •1.Subjects who are pregnant, breast feeding, or planning to become pregnant during the study.
- •2.Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
- •3.Have participated in any interventional clinical trial in the previous 30 days.
- •4.Have a known sensitivity to sorbitol and any of the constituents of the test product.
- •5.Have a history of alcohol or illegal drug/ substance abuse or suspected alcohol or illegal drug/substance abuse in the past 2 years.
- •6.Patients with Cholecystectomy.
- •7.Subject with an elevated level of calcium.
结局指标
主要结局
Change in SGA self-evaluation score
时间窗: Time frame 0-1 day | Time frame 0-1 day
Change in RDQ score
时间窗: Time frame 0-1 day | Time frame 0-1 day
次要结局
- Not applicable(Not applicable)
