CTRI/2022/10/046499
Completed
未知
An open label, randomized, placebo-controlled, clinical study to evaluate the safety and efficacy of Evocus Black Alkaline Drink in body Hydration, Acidity regulation and Detoxification among healthy, adult subjects.
A V Organics0 sites34 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- A V Organics
- Enrollment
- 34
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Age: 18 to 60 years (both inclusive) at the time of consent.
- •2\) Sex: Healthy Male and non\-pregnant/non\-lactating female.
- •3\) BMI between 18\.5 to 29\.9\.
- •4\) Subjects having either of the classical sign and symptoms of gastroesophageal reflux disease (GERD) i.e., Stomachache, Heartburn, Heavy Stomach, Lower Abdominal Pain and Bloated Stomach at the time of screening.
Exclusion Criteria
- •1\) Underweight or obese subjects (BMI \<18\.5 and \>\=30\).
- •2\) Currently taking any medication for diuretic, blood thinning or blood pressure medicines).
- •3\) Any Chronic illness or health condition such as cancer, diabetes, Peripheral Artery Disease, CKD, previous major surgery, HIV, hepatitis etc. that can interfere with the outcome of the study.
- •4\) Subjects working in harsh condition or are exposed to sun for most of the day (e.g., labourers), or in night shifts.
- •5\) Any pathological problem associated with gastroesophageal reflux disease including Barretts esophagus and malignancy
Outcomes
Primary Outcomes
Not specified
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