| CTRI Number |
CTRI/2022/10/046499 [Registered on: 14/10/2022] Trial Registered Prospectively |
| Last Modified On: |
13/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Non-Carbonated water based beverage] |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate the Safety and Effectiveness of Alkaline Drink on Body Hydration, Acidity Regulation and Detoxification. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B02458; Version: 01, Dated 21 Sep 22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Block 17-20, Sigma I Corporates,
Opp. Mann Party Plot,
Off S.G. Highway,
Bodakdev, Ahmedabad-380054.
Phone: 079 66135601
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Block 17-20, Sigma I Corporates,
Opp. Mann Party Plot,
Off S.G. Highway,
Bodakdev, Ahmedabad-380054.
Phone: 079 66135601
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
|
| Email |
pjoshi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director-Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Block 17-20, Sigma I Corporates,
Opp. Mann Party Plot,
Off S.G. Highway,
Bodakdev, Ahmedabad-380054.
Phone: 079 66135601
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
|
Source of Monetary or Material Support
|
| A V Organics
4th Floor, Emerald Building,
Near Chakli Circle,
Vadodara, Gujarat – 390007 |
| Cliantha Research
Consumer Research Department,
Block 17-20, Sigma I Corporates,
Opp. Mann Party Plot,
Off S.G. Highway,
Bodakdev, Ahmedabad-380054. |
|
|
Primary Sponsor
|
| Name |
A V Organics |
| Address |
4th Floor, Emerald Building,
Near Chakli Circle,
Vadodara, Gujarat – 390007
Phone: 08999000000 |
| Type of Sponsor |
Other [Manufacturing & bottling of beverages] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parth Joshi |
Cliantha Research |
Consumer Research Department,
Block 17-20, Sigma I Corporates,
Opp. Mann Party Plot,
Off S.G. Highway,
Bodakdev, Ahmedabad 380054.
Phone 079 66135601
Ahmadabad
GUJARAT |
8000085049
pjoshi@cliantha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adult subjects of both genders with age between 18 and 60 years (both inclusive at the time of consent). |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Evocus Black Alkaline Drink |
Subjects will be instructed to consume specified liters per day. Product will be taken for duration of 60 days. |
| Comparator Agent |
Purified RO water of well-known brand or other equivalent packaged drinking water conforming to BIS 14543 / Mineral Water of well-known brand or equivalent natural mineral water conforming to BIS 13428. |
Subjects will be instructed to consume specified liters per day. Product will be taken for duration of 60 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
Baseline, Day 15, Day 30, Day 45, Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/10/2022 |
| Date of Study Completion (India) |
09/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This
is an open label, randomized, placebo-controlled, two-arm clinical study to
evaluate the efficacy and safety of Evocus Black Alkaline Drink in healthy
adult subjects.
The
potential subjects will be screened as per the inclusion and exclusion criteria
only after obtaining written informed consent from the subjects.
There
are total 06 visits in the study i.e., - Visit 01: Screening Visit (Within 7 days from
Day 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) |