| CTRI Number |
CTRI/2025/01/079826 [Registered on: 31/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study on Alkaline water in healthy participants with Alcohol Hangover |
|
Scientific Title of Study
|
A Randomized, Controlled, Double Blind clinical study to evaluate use of Hydron Alkaline Ionised Water (HAIW) in healthy participants with Alcohol Hangover |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HAIW /HANGO/2024/01, Version 1.0, 17th 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. Gastroenterology Department, OPD, no. 1o, Ground Floor, 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. Medical Department, A wing, Office 402, 4th Floor, 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. Medical Department, A wing, Office 402, 4th Floor, 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 |
| Type of Sponsor |
Other [Healthcare Industry] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhushan Bapusaheb Mogal |
Ayurved seva sanghs, Ayurved Mahavidyala, |
Dep.of Agadtantra, OPD No. 9, Ground Floor, Ganeshwadi, Nashik, 422003
Nashik
MAHARASHTRA |
9730139911
bhushanbmogal@gmail.com |
| Dr Asharani Medidar |
Seth Govindji Raoji Ayurved Mahavidyalaya and Hospital, Solapur |
Department of Panchakarma
OPD no 02, Ground floor, Opp Ayurved College Police Chowky New Budhwar Peth Samrath Chowk, Solapur, Maharashtra 413001
Solapur
MAHARASHTRA |
8830429540
asharani.medidar@sgrayurved.edu.in |
| Dr Ksheetij Kothari |
Shivam Multispecialty & Accident Care Centre Pvt. Ltd. |
Gastroenterology Department, OPD, no. 10, Ground Floor, Opp. Riverview City, Solapur - Pune Hwy, Haveli, Taravadi, Phursungi, Tal. Haveli Pune 412308
Pune
MAHARASHTRA |
9765180182
ksheetij.kothari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| 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 |
Approved |
| Institutional Ethics Committee Seth Sakharam Nemchand Jain Aushadhalaya Trusts Seth Govindraoji Ayurved Mahavidhya and Seth Sakharam Nemchand Jain Ayurveda Rugnalaya Solapur |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Alcohol Hangover |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hydron Alkaline Ionised Water (HAIW) |
Subject will be asked to consume HAIW as and even required for 15 days. |
| Comparator Agent |
Packaged Drinking water |
Subject will be asked to consume Packaged Drinking water as and even required for 15 days. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Literate healthy male and female participants self-reporting to be moderate drinkers of alcohol, which is approximated to usual drinking occasions (corresponding to 2 to 5 or 3 to 7 alcoholic drinks for a 70 kg female and male, respectively, over a 2 to 3 h period) and having any of the symptoms of hangover of mild to moderate severity
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. Subjects being treated for cardiovascular (high blood pressure), immune,
respiratory, endocrine (diabetes), gastrointestinal, liver, biliary tract, kidney
and urinary, nervous, and musculoskeletal system, psychiatric, infectious, and
thyroid diseases, malignant tumors, or a history of peptic ulcer, reflux
esophagitis, or gastrointestinal surgery
2. Pregnant or planning to become pregnant, nursing mothers,
3. Subjects with alcohol use disorder, alcoholism, substance abuse, or were
taking an anti-abuse drug or warfarin, clopidogrel, aspirin, or non-steroidal
anti-inflammatory drugs.
4. Subjects with abnormal creatinine (two times the standard upper limit),
aspartate aminotransferase (AST), or alanine transaminase (ALT) (three times
the standard upper limit) levels.
5. Participants who participated in other interventional clinical trials within 1
month or planned to participate in other interventional clinical trials
6. Participants sensitive or allergic to alkaline water
7. Participants with known history of hepatitis B and or C, diabetes mellitus,
hypertension, cancer
8. 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 |
| Assessment of Alcohol Hangover Severity Scale (AHSS) |
Screening visit (up to 3 days), Baseline visit (Day 0), telephonic follow ups and Day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Global assessment for overall change by investigator and by participant
2. Assessment of tolerability of study products by assessing adverse events and
Adverse drug reactions
3. Assessment of adverse events and vitals
|
Screening visit (up to 3 days), Baseline visit (Day 0), telephonic follow ups and Day 15 |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2025 |
| 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="4"
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, controlled,
double blind clinical study to evaluate use of Hydron Alkaline Ionised Water
(HAIW) in healthy participants with Alcohol Hangover. The study will be carried
out at 3 to 4 centres 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 15 days. The primary
objectives of the study will be to assess subjects on Alcohol Hangover Severity
Scale (AHSS). The secondary objectives of the study will be to assess global assessment for overall change by
investigator and by participant, tolerability of study products by assessing
adverse events /Adverse drug reactions and adverse events and vitals on
screening visit (up to 3 days), Baseline visit (Day 0), telephonic follow ups
and Day 15 |