An Open Label, Pilot Clinical Study on Finding the Effect of a Food Supplement (Enzoveda#001) on Indigestion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To assess efficacy of Enzoveda#001 as a food supplement in patients suffering from indigestion and mean change in Visual Analogue Scale (VAS) from baseline to end of treatment.
研究概览
简要总结
This is an open label, pilot clinical study on finding the effect of a food supplement on Indigestion.
The primary objective of this study is to assess safety and efficacy of Enzoveda#O01- as a food supplement in patients suffering from indigestion.
The secondary objective of this study is to assess Relief in symptoms of Indigestion. lt will assessed by Visual Analog Scale {VAS}
All eligible subjects who meet the Inclusion and Exclusion will be enrolled into the study will have to visit the study site on screening, Day 0 (Baseline visit) and Day 7. 10 subjects will be enrolled.Subjects in study will receive active Investigational Product and advised to take one sachet three times a day after food.
Demographic data such as Age, Gender, Weight, Vitals will be summarized using descriptive statistics along with Visual Analog Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •The Inclusion criteria are as follows (“Yes†to all the following will allow the subjects to be included into study)
- •Age: Adult-Above 18 years to 60 years, both male and female
- •Willing to sign written inform consent
- •Patients diagnosed one of the following signs and symptoms of indigestion Abdominal discomfort Flatulence Burping or belching Acidity and pain Heaviness in upper abdomen.
排除标准
- •The exclusion criteria are as follows (“Yes†to any one of the following will allow PI to exclude the subject from enrolling into the study
- •Patients below 18 years and above 60 yrs.
- •Not willing to sign written inform consent
- •Allergic reactions to enzymes of similar composition.
- •Gastrointestinal disease or other condition resulting in inability to take oral medications
- •Uncontrolled heart disease or other serious chronic disease
- •Patients suffering from chronic major illness, like- Hypertnesion, Jaundice, AIDS, Cancer, Tuberculosis, Diabetes Mellitus, Hepatitis B or C positive etc
- •Use of investigational agents within 4 weeks of randomization
- •Concurrent systemic corticosteroid therapy within 4 weeks of randomization.
- •Seriously ill and moribund patients with complications.
- •Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test.
结局指标
主要结局
To assess efficacy of Enzoveda#001 as a food supplement in patients suffering from indigestion and mean change in Visual Analogue Scale (VAS) from baseline to end of treatment.
时间窗: 7 days
次要结局
- Symptomatic relief from the symptoms of Indigestion(7 days)