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A study to evaluate the Safety and Effectiveness of Alkaline Drink on Body Hydration, Acidity Regulation and Detoxification.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/10/046499
Enrollment
36
Registered
2022-10-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Evocus Black Alkaline Drink: Subjects will be instructed to consume specified liters per day. Product will be taken for duration of 60 days. Control Intervention1: Purified RO water of

Sponsors

A V Organics
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Simran Sethi

Cliantha Research

pjoshi@cliantha.com8000085049

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026