CTRI/2025/01/079462 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On:
04/08/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Other (Specify)
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Clinical study on Alkaline Water on healthy participants with digestive complaints
Scientific Title of Study
A Randomized, Controlled, Double Blind clinical study to evaluate use of Hydron Alkaline Ionised Water (HAIW) in healthy participants with digestive complains - hyperacidity and functional constipation
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
HAIW /ACI&CONS/2024/01, Version 1.0, 7th Oct 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ksheetij Kothari
Designation
Gastroenterologist Consultant
Affiliation
Shivam Multispecialty & Accident Care Centre Pvt. Ltd.
Address
Shivam Multispecialty & Accident Care Centre Pvt. Ltd.
Ground Floor, Gastroenterology department, OPD no. 10, Opp. Riverview City, Solapur - Pune Hwy, Taravadi, Phursungi, Tal. Haveli,Pune
Pune MAHARASHTRA 412308 India
Phone
9765180182
Fax
Email
ksheetij.kothari@gmail.com
Details of Contact Person Scientific Query
Name
Dr Sanjay Tamoli
Designation
Director
Affiliation
Target Institute of Medical Education and Research Pvt. Ltd
Address
Target Institute of Medical Education and Research Pvt. Ltd,
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
Mumbai (Suburban) MAHARASHTRA 400064 India
Phone
9322522252
Fax
Email
targetinstitute@yahoo.com
Details of Contact Person Public Query
Name
Dr Sanjay Tamoli
Designation
Director
Affiliation
Target Institute of Medical Education and Research Pvt. Ltd
Address
Target Institute of Medical Education and Research Pvt. Ltd,
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai
MAHARASHTRA 400064 India
Phone
9322522252
Fax
Email
targetinstitute@yahoo.com
Source of Monetary or Material Support
Hydron Alkaline Aqua Pvt. Ltd. 4A, Trust House, 35 Hospital Avenue, Dr E
Borges Road, Parel Mumbai 400012
Primary Sponsor
Name
Hydron Alkaline Aqua Pvt. Ltd.
Address
4A, Trust House, 35 Hospital Avenue, Dr E
Borges Road, Parel Mumbai 400012
Department of General OPD,
OPD No. 1, First Floor, B Wing, Jay
Ganesh Samrajya,Nashik Hwy,Sector No. 3, Bhosari, Pune,Pimpri-Chinchwad, Maharashtra 411039
Pune MAHARASHTRA
7776008686
sarikalondhe49@gmail.com
Dr Santosh Swami
Seth Govindji Raoji Ayurved Mahavidyalaya and Hospital
Department – Kayachikitsa
OPD no 02. Ground Floor
Seth Govindji Raoji Ayurved Mahavidyalaya and Hospital, Police Chowky New Budhwar Peth Samrath Chowk, Solapur, Maharashtra - 413002
Solapur MAHARASHTRA
9422957234
santoshswami2009@gmail.com
Dr Ksheetij Kothari
Shivam Multispecialty & Accident Care Centre Pvt. Ltd.
Ground Floor, OPD No. 10, Gastroenterology Department, Opp. Riverview City, Solapur - Pune Hwy, Taravadi, Phursungi, Tal. Haveli Dist Pune 412308
Pune MAHARASHTRA
9765180182
ksheetij.kothari@gmail.com
Details of Ethics Committee
No of Ethics Committees= 4
Name of Committee
Approval Status
Institutional Ethics Committee Ayurveda Seva Sangh’s, Ayurveda Mahavidyalaya Nashik
Approved
Institutional Ethics Committee Dr. Mhaske Hospital & Research Centre Pvt. Ltd. Hadapsar, Pune
digestive complains - hyperacidity and functional constipation
Intervention / Comparator Agent
Type
Name
Details
Intervention
Hydron Alkaline Ionized Water (HAIW)
Subject will be asked to consume HAIW as and even required for 30 days.
Comparator Agent
Packaged Drinking water
Subject will be asked to consume Packaged Drinking water as and even required for 30 days.
Inclusion Criteria
Age From
18.00 Year(s)
Age To
60.00 Year(s)
Gender
Both
Details
Cohort 1:
1. Healthy males and females with any of the mild to moderate symptoms including bloating, feeling of acid reflux, early fullness during a meal, pain, or discomfort in the upper abdomen, burning in the upper abdomen, pain/burning in the center of chest, nausea, vomiting, burping, flatulence, indigestion, and appetite.
2. Subjects must be suffering from any of the above symptoms at least from
last six months.
3. Subjects willing to follow the procedures as per the study protocol and
voluntarily sign an informed consent form.
Cohort 2:
1. Male or female subjects presenting with any two symptoms i.e. straining during defecation, lumpy or hard stool, sensation of incomplete evacuation, sensation of
anorectal blockade for the last 3 months
2. Subjects who are ready to provide written informed consent and who are
ready to willingly participate and follow the protocol requirements of the
clinical study
ExclusionCriteria
Details
Cohort 1:
1. Subjects with known tuberculosis, hepatitis B and C, HIV, ischemic heart
disease, cancer, kidney failure, chronic liver diseases,
2. Subjects having jaundice or any other symptom of active hepatitis
3. Subjects with any other investigational product within 1 month prior to
randomization
4. Subject suffering from any other functional dyspepsia, or any other
functional gastrointestinal disorder
5. Subjects with diabetes mellitus and hypertension taking regular medications
6. Pregnant and lactating women
7. Subjects with any significant abnormal laboratory parameters
8. Known hypersensitivity to study products
9. Other conditions, which in the opinion of the investigators makes the patient
unsuitable for enrolment or could interfere in adherence to of the study protocol.
Cohort 2:
1. Subjects diagnosed with colonic inertia., have recently undergone abdominal surgery, history of anorectal surgery.
2.Subjects having other functional gastrointestinal disorders other than Functional
constipation
3. Subjects diagnosed with structural abnormalities
4. Subjects with uncontrolled DM and hypertension and Tuberculosis.
5. Known cases of HIV, tuberculosis, hypo and hyperthyroidism
6. Known cases of renal or liver dysfunction.
7. Subjects diagnosed with neurological
8. Subjects on chronic medication greater than 60 days and or who are on medications known to cause constipation.
9. Pregnant or lactating females
10. Subjects allergic to Hydron Alkaline Ionised Water (HAIW) or packaged
drinking water
11. Other conditions, which in the opinion of the investigators makes the patient
unsuitable for enrolment or could interfere in adherence to of the study protocol.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Cohort 1:
Change in severity of gastrointestinal symptoms assessed on graded scale
Cohort 2:
Change in frequency of bowel movements
Baseline visit, day 15 and day 30
Secondary Outcome
Outcome
TimePoints
Cohort 1:
1. Changes in duration, number of episodes and severity of symptoms on graded scale
2. Changes in indigestion and appetite
3. Global assessment for overall change by investigator and subject
4. Global assessment of tolerability of study product by assessing ADRs, vitals and clinical symptoms
5. Assessment of adverse events
Cohort 2:
1. Changes in indigestion and appetite on graded scale
2. Changes in symptoms of functional constipation on graded scale
3.Changes in associated clinical symptoms on graded scale
4. Global assessment of overall change as per the investigator and subject
5. Assessment of tolerability of study product as per the investigator and subject by assessing Adverse Events, Adverse Drug Reactions
Baseline visit, day 15 and day 30
Target Sample Size
Total Sample Size="200" Sample Size from India="200" Final Enrollment numbers achieved (Total)= "215" Final Enrollment numbers achieved (India)="215"
Phase of Trial
Phase 2/ Phase 3
Date of First Enrollment (India)
05/02/2025
Date of Study Completion (India)
07/04/2025
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="4" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
It is a randomized, controlled, double blind clinical study to evaluate use of Hydron Alkaline Ionised Water (HAIW) in healthy participants with digestive complains - hyperacidity and functional constipation. There will be two cohorts in the study. In cohort 1, healthy subjects with hyperacidity will be enrolled and in cohort 2, healthy subjects with functional constipation will be enrolled. The study will be carried out in 4 to 5 centers in India. As per computer generated randomization list, subjects will be randomized either to HAIW Group or Packaged Drinking Water in 1:1 ratio. Subject will be asked to consume either HAIW or Packaged Drinking water as and even required for 30 days.
Cohort 1:
The primary objective of the study will be to assess change in severity of gastrointestinal symptoms assessed on graded scale. The secondary objectives of the study will be to assess changes in duration, number of episodes and severity of symptoms including bloating, feeling of acid reflux, early fullness during a meal, pain or discomfort in the upper abdomen, burning in the upper abdomen, pain/burning in the center of chest, nausea, vomiting, burping, and flatulence, changes in indigestion and appetite, global assessment for overall change by investigator and subject, global assessment of tolerability of study product by assessing ADRs, vitals and clinical symptoms and assessment of adverse events on baseline visit, day 15 and day 30.
Cohort 2:
The primary objective of the study will be to assess change in frequency of bowel movements. The secondary objectives of the study will be to assess changes in indigestion and appetite on graded scale, changes in symptoms of functional constipation including straining on defecation, sensation of incomplete evacuation, sensation of ano-rectal blockage, manual maneuvers required & average time spent for bowel evacuation on graded scale, changes in associated clinical symptoms including headache, belching, flatulence, abdominal distension/bloating, acidity on graded scale, global assessment of overall change as per the investigator and subject and assessment of tolerability of study product as per the investigator and subject by assessing Adverse Events/Adverse Drug Reactions on baseline visit, day 15 and day 30.
Results and Observations:
The study concludes that consumption of HAIW
showed a significant reduction in symptoms of hyperacidity like acid reflux,
pain in abdomen, bloating, burning sensation in the chest and flatulence. These
effects were observed within 15 days of starting consuming HAIW and continued
further till 30 days. The reduction in these symptoms were found to be
significantly better as compared to packaged drinking water. In participants suffering from constipation a
non-significant difference was observed between the two groups, HAIW and PDW on
bowel habits (frequency, straining etc). In these participants also there was a
significantly better improvement in indigestion with the consumption of HAIW as
compared to PDW.