| CTRI Number |
CTRI/2025/02/080997 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Alkaline Water] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical Study on Alkaline Water in Health & Immunity Related Parameters |
|
Scientific Title of Study
|
A Randomized, Open label, Multi-centric, Comparative, Prospective, Interventional, Clinical Study to evaluate use of Hydron Alkaline Ionised Water (HAIW) in Health & Immunity Related Parameters |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HAIW/HIRP/2025/01, Version 1.0, 03rd Jan 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nilesh Londhe |
| Designation |
Consultant Physician |
| Affiliation |
Nirvikar Ayurveda Hospital |
| Address |
Department of General OPD, OPD No. 1, First Floor,
Nirvikar Ayurveda Hospital, B Wing, Jay Ganesh Samrajya, Nashik Hwy,Sector No. 3, Bhosari, Pune,Pimpri-Chinchwad
Pune
MAHARASHTRA
411039
India |
| Phone |
9881572395 |
| Fax |
|
| Email |
drnileshlondhe@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 Ld. Department of Clinical Research, 4th Floor, A wing office no 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 Ld. Department of Clinical Research, 4th Floor, A wing office no 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 |
|
|
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
|
| Type of Sponsor |
Other [Healthcare Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santosh Pathak |
Ayurved Seva Sangh, Ayurved Mahavidyalaya |
Department of Shalyatantra
OPD No. 6, Ground Floor,
Ganeshwadi, Nashik-422003
Nashik
MAHARASHTRA |
9405369727
drsantoshp@gmail.com |
| Dr Nilesh Londhe |
Nirvikar Ayurveda Hospital |
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 |
9881572395
drnileshlondhe@gmail.com |
| Dr Santosh Swami |
Seth Govindji Raoji Ayurved Mahavidyalaya and Hospital |
Department of Kayachikitsa
OPD no 02, Ground floor
21-A/13, Budhwar Peth, Samrat Chowk, Solapur, Maharashtra - 413002
Solapur
MAHARASHTRA |
9422957234
santoshswami2009@gmail.com |
| Dr Shailesh Suryakant Kanchan |
Shivam Multispecialty &Accident Care Centre Pvt. Ltd |
General Medicine Department, Ground Floor, OPD no 10
Opp. Riverview City, Near Loni Toll Naka,
Solapur - Pune Hwy, Haveli, Phursungi, Tal. Haveli, Pune Maharashtra 412308
Pune
MAHARASHTRA |
9011870368
drshaileshkanchan@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 |
Submittted/Under Review |
| Institutional Ethics Committee Dr. Mhaske Hospital & Research Centre Pune |
Submittted/Under Review |
| Institutional Ethics Committee Seth Sakharam Nemchand Jain Aushadhalaya Trusts Seth Govindraoji Ayurved Mahavidhya Seth Sakharam Nemchand Jain Ayurveda Rugnalaya Solapur |
Submittted/Under Review |
| Institutional Ethics Committee, Nirvikar Ayurveda Hospital Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health and Immunity Related Parameters |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydron Alkaline Ionized Water (HAIW) |
Dosage and Duration:
Subject will be asked to consume HAIW as and even required for 90 days
|
| Comparator Agent |
Packaged Drinking Water |
Dosage and Duration:
Subject will be asked to consume Packaged Drinking water as and even required for 90 days
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy, Male or Female subjects
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 |
1. Pregnant and Lactating females
2. Uncontrolled cases of Diabetes and Hypertension
3. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening
4. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc.
5. Subjects taking steroid treatment and or any kind of immunosuppressive therapy
6. Subjects participating in any other clinical study or having participated in any
other study 3 months prior to screening in the present study.
7. Subjects having allergy to alkaline water
8. 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
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparative assessment of immunity fitness by measuring immunity parameters on self-reported scales |
Screening/ Baseline Visit (Day 0), Day 30, Day 60, Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparative assessment of difference of absent days in office or workplace due to infections or allergies
2. Comparative assessment of number of participants for absent days in office or workplace due to infections or allergies
3. Comparative assessment of change in energy levels, physical fitness, strength and stamina
4. Comparative assessment of number of participants having change in energy levels, physical fitness, strength and stamina
5. Comparative assessment of change in quality of life as assessed using WHO QOL BREF
6. Comparative assessment of Physician’s and Subject’s Global evaluation for overall Change on CGI-I Scale
7. Assessment of incidence of adverse events, serious adverse events and vitals.
|
Screening/ Baseline Visit (Day 0), Day 30, Day 60, Day 90 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a randomized, open label, multi-centric, comparative, prospective, interventional, clinical study to evaluate use of Hydron Alkaline Ionised
Water (HAIW) in Health & Immunity Related Parameters. The study will be carried out in 4 to 5
centers across 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 90 days. The primary
objective of the study will be to assess immunity fitness by measuring immunity
parameters on self-reported scales. The secondary objectives of the study will
be to assess difference of absent days in office or workplace due to infections
or allergies, number of participants for absent days in office or workplace due
to infections or allergies, change in energy levels, physical fitness, strength
and stamina, number of participants
having change in energy levels, physical fitness, strength and stamina, quality
of life as assessed using WHO QOL BREF, Physician’s and Subject’s Global
evaluation for overall Change on CGI-I Scale and incidence of adverse events,
serious adverse events and vitals on Screening/ Baseline Visit (Day 0),
Day 30, Day 60, Day 90 |