| CTRI Number |
CTRI/2024/06/068585 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
21/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study on Alkaline Water in healthy subjects |
|
Scientific Title of Study
|
A Randomized, Controlled, Double Blind clinical study to evaluate use of Hydron Alkaline Ionized Water (HAIW) in healthy participants |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HAIW/2024/01, Version 1.0, 15th May 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vineet Kumar Malhotra |
| Designation |
Consultant Physician |
| Affiliation |
Shivam Multi-speciality and Accident Care Centre Pvt. Ltd |
| Address |
OPD No.1 Ground Floor,
Shivam Multi-speciality and Accident Care
Centre Pvt. Ltd, opposite to Riverview, Oppo to Loni Toll Naka Solapur-Pune Hwy, Tarawadi, Phursungi Tal. Haveli, Maharashtra
Pune
MAHARASHTRA
412308
India |
| Phone |
9404226170 |
| Fax |
|
| Email |
vinekmalhotra@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 400064
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 400064
Mumbai (Suburban)
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 Vineet Kumar Malhotra |
Shivam Multispecialty and Accident Care Centre Pvt. Ltd. |
OPD No.1 Ground Floor, Department of Medicine
Shivam Multi-speciality and Accident Care
Centre Pvt. Ltd, opposite to Riverview, Oppo to Loni Toll Naka
Solapur-Pune Hwy, Tarawadi, Phursungi Tal. Haveli, Maharashtra
Pune
MAHARASHTRA |
09404226170
vinekmalhotra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Ethics Committee, Mhaske Hospital and Research Centre, Hadapsar, Pune. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydron Alkaline Ionized Water (HAIW) |
Dosage and Treatment Duration:
Subjects will be asked to drink at least 3 Liters of HAIW apart from the water used for food for 7 days
|
| Comparator Agent |
Packaged Drinking Water (PDW) |
Dosage and Treatment Duration:
Subjects will be asked to drink at least 3 Liters of PDW apart from the water used for food for 7 days
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy Male and Female participants in the age group of 21-40 Years
2. Subjects of female gender or non-pregnant, non-lactating females. A urine pregnancy test is required for all female subjects of childbearing potential unless female subject has had a hysterectomy, tubal ligation, or is greater than 2 years postmenopausal.
3. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
|
|
| ExclusionCriteria |
| Details |
1. Known cases of any Severe and Chronic disease.
2. Known subject of any active malignancy.
3. Subjects giving history of significant cardiovascular event less than 12 weeks prior to randomization.
4. Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
5. Known subjects of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
6. Subjects with Diabetes and Hypertension
7. Subjects using any other investigational drug within 1 month prior to recruitment.
8. Known hypersensitivity to alkaline water
9. Pregnant and Lactating females.
10. Subjects currently participating in any other Clinical study.
11. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Safety related lab parameters including CBC, LFT, RFT, Blood Sugar, ECG, Sr. Electrolytes
2. Safety by evaluation of adverse events based on clinical signs and symptoms
|
Screening visit (Day -3), Baseline visit (Day 0), Every day till next 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in digestion related symptoms (appetite, digestion, bowel habits)
2. Change in urine output and symptoms
3. Change in sleep quality
4. Change in overall quality of life
5. Change in level of Energy, level of stamina and physical strength
6. Change in daytime fatigue using Fatigue Severity Scale (FSS)
7. Change in Global evaluation for overall change on CGI-I Scale by physician and subjects
8. Change in global assessment of overall safety by physician and subjects |
Screening visit (Day -3), Baseline visit (Day 0), Every day till next 7 days |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
17/06/2024 |
| Date of Study Completion (India) |
01/07/2024 |
| 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
|
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 Ionized Water (HAIW) in healthy participants. The study will be carried out in 1 centre in India. As per computer generated randomization list, subjects will be randomized either to HAIW Group or Packaged Drinking water Group in 1:1 ratio. During stay in the hospital subjects will be asked to consume at least 3 Liters of HAIW or PDW apart from the water used for food and refreshments. The primary objectives of the study will be to assess safety related lab parameters including CBC, LFT, RFT, Blood Sugar, ECG, Sr. Electrolytes and safety by evaluation of adverse events based on clinical signs and symptoms. The secondary objectives of the study will be to assess changes in digestion related symptoms (appetite, digestion, bowel habits), change in urine output and symptoms, change in sleep quality, change in overall quality of life, change in level of Energy, level of stamina and physical strength, change in daytime fatigue using Fatigue Severity Scale (FSS), change in Global evaluation for overall change on CGI-I Scale by physician and subjects, and change in global assessment of overall safety by physician and subjects on screening visit (Day -3), baseline visit (Day 0), every day till next 7 days
Summary of Results: The study concludes that HAIW was well tolerated by all the study participants without causing any adverse effects. All safety related laboratory parameters showed no significant change over a period of 7 days. HAIW showed significant improvement in digestive system like appetite, digestion and bowel habits. There was a significant improvement in sleep quality and freshness after waking up with the use of HAIW as compared to PDW. All the vital parameters remained within normal range in both the groups throughout the study period and showed non-significant change between HAIW and PDW. Urine parameters showed non-significant change from baseline to 7 days and between the groups.
The study concludes that HAIW can be safely without causing any adverse effects and improves function like digestion and sleep. |