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

Completed

• Conditions: Adult subjects of both genders with age between 18 and 60 years (both inclusive at the time of consent).

• Registration Number: CTRI/2022/10/046499
• Lead Sponsor: A V Organics

Brief Summary

Thisis an open label, randomized, placebo-controlled, two-arm clinical study toevaluate the efficacy and safety of Evocus Black Alkaline Drink in healthyadult subjects.

Thepotential subjects will be screened as per the inclusion and exclusion criteriaonly after obtaining written informed consent from the subjects.



Thereare total 06 visits in the study i.e.,

- Visit 01: Screening Visit (Within 7 days fromDay 01) (Day 00)

- Visit 02: Enrolment Phase (Day 01)

- Visit 03: Evaluation Phase (Day 15 ± 02 Days)

- Visit 04: Evaluation Phase (Day 30 ± 02 Days)

- Visit 05: Evaluation Phase (Day 45 ± 02 Days)

- Visit 06: Evaluation Phase and End of the study(Day 60 ± 02 Days)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-21
• Last Update Posted: 2023-04-13
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5) Assessment of test product on Detoxification Subjective Questionnaire.	Baseline, Day 15, Day 30, Day 45, Day 60
1) Assessment of body hydration level using Bioelectrical Impedance Analysis (BIA).	Baseline, Day 15, Day 30, Day 45, Day 60
2) Assessment of Gastrointestinal symptoms in GERD questionnaire on 4-point scale.	Baseline, Day 15, Day 30, Day 45, Day 60
3) Assessment of test product on Defecation and urination (Urinary frequency, Fecal properties, Bowel movement) by questionnaire.	Baseline, Day 15, Day 30, Day 45, Day 60
4) Assessment of test product on Physical condition (Sleep quality) on 3-point scale.	Baseline, Day 15, Day 30, Day 45, Day 60

Secondary Outcome Measures

Name	Time	Method
Assessment of test product on mean % change in immunity markers by measuring NK cell activity.	Baseline, Day 60
Assessment of test product on change in comprehensive gut microflora by NGS	Baseline, Day 60

Trial Locations

Locations (1)

Cliantha Research; 🇮🇳 Ahmadabad, GUJARAT, India

Cliantha Research

🇮🇳Ahmadabad, GUJARAT, India

Dr Parth Joshi

Principal investigator

8000085049

pjoshi@cliantha.com