None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion 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
Exclusion criteria: 1) Underweight or obese subjects (BMI =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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Assessment of body hydration level using Bioelectrical Impedance Analysis (BIA). 2) Assessment of Gastrointestinal symptoms in GERD questionnaire on 4-point scale. 3) Assessment of test product on Defecation and urination (Urinary frequency, Fecal properties, Bowel movement) by questionnaire. 4) Assessment of test product on Physical condition (Sleep quality) on 3-point scale. 5) Assessment of test product on Detoxification Subjective Questionnaire.Timepoint: Baseline, Day 15, Day 30, Day 45, Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of test product on change in comprehensive gut microflora by NGSTimepoint: Baseline, Day 60;Assessment of test product on mean % change in immunity markers by measuring NK cell activity.Timepoint: Baseline, Day 60 | — |
Countries
India
Contacts
Cliantha Research