| CTRI Number |
CTRI/2025/01/078941 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Healthcare ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study on Alkaline Water in stress and sleep problem |
|
Scientific Title of Study
|
A Randomized, Controlled, Double Blind clinical study to evaluate use of Hydron Alkaline Ionised Water (HAIW) in healthy participants with stress and insomnia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HAIW /STRE&INSOM/2024/01, Version 1.0, 07th Oct 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sandeep Shinde |
| Designation |
Consultant Physician |
| Affiliation |
Shivam Multispecialty & Accident Care Centre Pvt. Ltd |
| Address |
Ground Floor, Medicine Department, OPD No 10.
Shivam Multispecialty & Accident Care Centre Pvt. Ltd. Opp. Riverview City, Taravadi, Phursungi, Tal. Haveli, Dist. Pune
Pune
MAHARASHTRA
412308
India |
| Phone |
9763332545 |
| Fax |
|
| Email |
drsandeep112@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 |
09322522252 |
| 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 |
09322522252 |
| 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 = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sandeep Shinde |
Shivam Multispecialty and Accident Care Centre Pvt. Ltd. |
Opposite Riverview, Opp Loni Toll Naka, Solapur-Pune Hwy, Taravadi, Phursungi Tal. Haveli, Dist Pune
Pune
MAHARASHTRA |
9763332545
drsandeep112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mhaske Hospital and Research Centre, Hadapsar, Pune. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z733||Stress, not elsewhere classified, (2) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydron Alkaline Ionised 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 |
21.00 Year(s) |
| Age To |
61.00 Year(s) |
| Gender |
Both |
| Details |
1.Healthy male and female participants who perceive themselves to be under stress and also having
insomnia
2. Participants willing to sign inform consent form
3. A female participant who is of reproductive potential has a negative pregnancy
test and agrees to use contraception throughout study period
|
|
| ExclusionCriteria |
| Details |
1. History or diagnosis of another sleep disorder
2. Difficulty sleeping due to a medical condition
3. History of a neurological disorder
4. History of bipolar disorder, psychotic disorder, or posttraumatic stress
disorder, or current psychiatric disorder that requires medication
5. On-going depression and generalized anxiety disorder
6. History of substance abuse or dependence
7. Taking certain prohibited medications (opium, cannabis (marijuana) and
Methamphetamines)
8. Participants with habit of smoking Cigarette etc.
9. Participants with known history of hepatitis B and or C, diabetes mellitus,
hypertension, cancer
10. History of malignancy less than or equal to 5 years prior to signing informed consent
11. Known hypersensitivity to alkaline water or packaged drinking water
12. Other conditions, which in the opinion of the investigators, makes the
participant unsuitable for enrolment or could interfere with his/her
participation in, and completion of the protocol
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in stress
2. Change in participant-reported total sleep time (as per participant diary)
|
Baseline visit, Day 15, Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Changes in sleep efficiency
2.Change in participant-reported time to sleep onset (as per participant diary)
3.Change in participant- reported number of awakenings (as per participant’s diary)
4. Change in participant -reported wake time after sleep onset
5. Change in daytime mood, ability to function at work, concentration and memory on a graded scale
6.Change in quality of Life
7.Change in fatigue as assessed on graded scale
8.Global assessment for overall change by investigator and by participants
9.Assessment of adverse events and vitals |
Baseline visit, Day 15, Day 30 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "72"
Final Enrollment numbers achieved (India)="72" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/01/2025 |
| Date of Study Completion (India) |
28/02/2025 |
| 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)?
Response - NO
|
Brief Summary
Modification(s)
|
It is a randomized, controlled, double blind clinical study to evaluate use of Hydron Alkaline Ionised Water (HAIW) in healthy participants with stress and insomnia. The study will be carried out at 3 to 4 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 given water as and even required for 30 days. The primary objectives of the study will be to assess change in stress and participant-reported total sleep time (as per participant diary). The secondary objectives of the study will be to assess changes in sleep efficiency, change in participant-reported time to sleep onset (as per participant diary), change in participant- reported number of awakenings (as per participant’s diary), change in participant -reported wake time after sleep onset, change in daytime mood, ability to function at work, concentration and memory on a graded scale, change in quality of Life, change in fatigue as assessed on graded scale, global assessment for overall change by investigator and by participants and adverse events and vitals on baseline visit, day 15 and day 30
Results and Observations:
The study concludes that the use of HIAW showed a significant reduction
in stress and improved sleep parameters like sleep efficiency and time to get
sleep. Also, significant improvement was observed in daytime functioning and
ability to work during the day with reduction in fatigue. Quality of life
measured on WHO QOL showed better quality of life with HIAW as compared to PDW
use with significant improvement in overall physical health. The use of HIAW
was found to be safe without causing any adverse effects |