| CTRI Number |
CTRI/2026/02/104715 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
27/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [ Efficacy Study] |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Effectiveness of Electrolyte drinks in Restoring Hydration during Dehydration in Healthy Adults |
|
Scientific Title of Study
|
Effectiveness of Electrolyte Drinks in Restoring Hydration during Dehydration: A Multicentered, Open label, Prospective Clinical Study in Healthy Adults |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CS2026DH100328 version 3.0 dated 20-Mar-2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nayan Patel MBBS |
| Designation |
Principal Investigator - Medical Director |
| Affiliation |
NovoBliss Research Private Limited |
| Address |
NovoBliss Research Pvt. Ltd.
313, 405 Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT
382481
India |
| Phone |
7948983895 |
| Fax |
|
| Email |
dr.nayan@novobliss.in |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Vijay Chamle |
| Designation |
Medical Head Baby India Restoration and Digestive Health APAC |
| Affiliation |
JNTL Consumer Health India Private Limited Kenvue Brands LLC |
| Address |
Kenvue Unit 2002 20th Floor Cignus Building Passpoli Village
Plot No 71 A Powai Mumbai India
Mumbai
MAHARASHTRA
400087
India |
| Phone |
9167302110 |
| Fax |
|
| Email |
VChamle@kenvue.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Purusothaman |
| Designation |
Senior Scientist R&D Translational Science |
| Affiliation |
JNTL Consumer Health (India) Private Limited (Kenvue Brands LLC) |
| Address |
Lal Bahadur Shashtri Marg Mumbai- Maharashtra India
Mumbai
MAHARASHTRA
400080
India |
| Phone |
9962695791 |
| Fax |
|
| Email |
PDivya01@kenvue.com |
|
|
Source of Monetary or Material Support
|
| Johnson & Johnson Pte Ltd, Offices at 2 Science Park Drive, Singapore Science Park 1, Ascent, #07-13, Singapore 118222
|
|
|
Primary Sponsor
|
| Name |
Johnson & Johnson Pte Ltd. |
| Address |
Offices at 2 Science Park Drive, Singapore Science Park 1, Ascent, #07-13, Singapore 118222 |
| Type of Sponsor |
Other [Consumer Health Company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| JNTL Consumer Health India Pvt Ltd Kenvue India |
Lal Bahadur Shashtri Marg Mumbai- 400080 Maharashtra India |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nayan Patel |
NovoBliss Research Private Limited |
NovoBliss Research Pvt. Ltd.
313, 405 Silver Radiance-4, Gota,
Ahmedabad, Gujarat, India - 382481.
Ahmadabad
GUJARAT |
07948983895
dr.nayan@novobliss.in |
| Dr Nirav Panchal |
Sycon Clinical Research Private Limited |
5th floor, Shree Sarju Arena,
Opp. Kadi Nagrik Bank, Zundal,
Gandhinagar-382421, Gujarat, India
Gandhinagar
GUJARAT |
9879503898
niravp@syconcro.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACEAS Independent Ethics Committee |
Approved |
| ACEAS Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Willing to restrict water intake for dehydration procedure |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
N/A |
| Intervention |
Test Electrolyte Drink - Variant 01 |
The electrolyte drinks (Sodium Chloride (0.26%), Potassium Chloride (0.15%), Ascorbic Acid (0.04%)) will be administered orally. Participants will consume 800 mL volume of the electrolyte drink under supervision of authorized study personnel. Dosing - Initial loading dose of 400 mL of 2 packs will be administered, and it should be consumed within 5 minutes. Follow-up Loading dose of another 400 mL will be administered after 1 hour of consumption of Initial Loading dose.
1 day (two doses administered on the same day, 1 hour apart) |
| Intervention |
Test Electrolyte Drink- Variant 03 |
The electrolyte drinks (Sodium Chloride (0.26%), Potassium Chloride (0.15%), Zinc Gluconate (0.123%), Sodium Selenate (0.000015%), Vitamin E (0.007%)) will be administered orally. Participants will consume 800 mL volume of the electrolyte drink under supervision of authorized study personnel. Dosing - Initial loading dose of 400 mL of 2 packs will be administered, and it should be consumed within 5 minutes. Follow-up Loading dose of another 400 mL will be administered after 1 hour of consumption of Initial Loading dose.1 day (two doses administered on the same day, 1 hour apart) |
| Intervention |
Test Electrolyte Drink-Variant 02 |
The electrolyte drinks (Sodium Chloride (0.26%), Potassium Chloride (0.15%), Ascorbic Acid (0.04%), Magnesium Sulphate (0.05%), Calcium Lactate (0.04%), Taurin (0.055%)) will be administered orally. Participants will consume 800 mL volume of the electrolyte drink under supervision of authorized study personnel. Dosing - Initial loading dose of 400 mL of 2 packs will be administered, and it should be consumed within 5 minutes. Follow-up Loading dose of another 400 mL will be administered after 1 hour of consumption of Initial Loading dose.
1 day (two doses administered on the same day, 1 hour apart) |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female
2. Adults with age range more than or equal to 18 to less than or equal to 35 years old
3. Healthy participants with no known interfering,limiting conditions based on detailed medical history reported by the participants and as judged by the PI.
4. Body mass index: 18.5 to 22.9 kg per m2
5. Salivary osmolarity 66-100 mOsm for confirmation of dehydration after dehydration procedure on Day 2.
6. Body mass loss more than or equal to 1 percent for confirmation on dehydration status after dehydration procedure on Day 2.
7. Able to read, write, speak, and understand either English or Local languages.
8. Participant has signed and dated informed consent document before participating in any study specific procedures, indicating the participant has been informed of all pertinent aspects of the study.
9. Agree to restrict fluid and consume dry food alone for at least 24 hours.
10. Willing to remain in-house during the study period.
11. The participant is able to comprehend the requirements of the study based upon clinical site personnel assessment and is willing and able to comply with scheduled visits, tests, and other study procedures specified within the protocol. |
|
| ExclusionCriteria |
| Details |
1. Participants following extreme dietary patterns (e.g., very low-fat or high-fat diets), specialized diets (such as ketogenic, paleo, or intermittent fasting), or those with evidence of disordered eating or intentional energy restriction within the last 1 month prior to screening.
2. Participants with any acute or chronic medical illness reported by the participants and as judged by the PI.
3. Participants using prescription or non-prescription medications at the time of inclusion that may interfere with hydration status, e.g., diuretics, cyclosporin, steroids or any other treatments that cannot be allowed in the study, in the opinion of the investigator.
4. Is taking a medication that would mask an Adverse Event (AE) or confound the study results, including:
• Immunosuppressive or steroidal drugs within 2 months before
Visit 1. *
• Non-steroidal anti-inflammatory drugs within 5 days before
Visit 1. *
• Antihistamines within 2 weeks before Visit 1.
• Medications or supplements known to affect fluid or electrolyte balance or renal function (e.g., hormonal contraceptives, ayurvedic or herbal medications).
* If an individual is taking one of these medication types, the individual is not considered eligible at screening. However, if a participant begins using one of these medications during the study, the Study Physician/PI should be consulted to consider the impact of the specific medication on participants safety and/or the study results as described in Protocol Section 4.3 (“Concurrent/Concomitant Medication”).
5. Female participants who are pregnant or lactating or planning to become pregnant during the study.
6. Has a history of or a concurrent health/other condition/situation which may put the individual at significant risk, confound the study results, or interfere significantly with the individual’s participation in the study at discretion of PI.
7. Participants with insomnia or sleep problems or with any sleep-disrupting factors (e.g. shift work, recent trans meridian flight).
8. Female participants who are currently menstruating at the time of assessment.
9. Participants who are hypersensitive to any components of the electrolyte drinks and/or having allergy to food in diet plan.
10. Participant is related to persons involved directly or indirectly with the conduct of this study (i.e., principal investigator, sub-investigators, study coordinators, other study personnel, employees of Kenvue subsidiaries, contractors of Kenvue, and the families of each).
11. Participants who are participating in a clinical trial and/or treated with any investigational product within 3 months preceding the first intake of study Investigational Product.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of the electrolyte drinks in achieving the hydration status in dehydrated participants within 2 hours after electrolyte drinks consumption assessed by salivary osmolality. |
Beginning 10 minutes after electrolyte drinks administration and then at 5-minute intervals (at the following timepoints 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 75, 80, 85, 90, 95, 100, 105, 110, 115, 120 min) until reaching the pre-defined euhydration threshold |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effectiveness of the electrolyte drinks in improvement of hydration level in dehydrated participants within 1 hour after electrolyte drinks consumption assessed by subjective perception questionnaire. |
Assess perceived hydration status at baseline and every 10 mins (at the following timepoints: 10, 20, 30, 40, 50, 60 mins |
| To assess the effectiveness of the electrolyte drinks in improvement of hydration level in dehydrated participants within 2 hours after electrolyte drinks consumption assessed by subjective perception questionnaire. |
Assess perceived hydration status at baseline and every 10 mins (at the following timepoints: 10, 20, 30, 40, 50, 60, 75, 85, 95, 105, 120 mins |
|
Target Sample Size
Modification(s)
|
Total Sample Size="99"
Sample Size from India="99"
Final Enrollment numbers achieved (Total)= "99"
Final Enrollment numbers achieved (India)="99" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/03/2026 |
| Date of Study Completion (India) |
04/05/2026 |
| 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)
|
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)
|
This study designed to investigate the effectiveness of electrolyte drinks in restoring hydration in the dehydrated participants. This is a multi-centered, open-label, interventional, prospective, clinical study of three variants of electrolyte drink in restoring hydration in dehydrated participants. A total of 99 healthy participants, including male and non-pregnant/ non-lactating female aged between 18 to 35 years (both inclusive) of age will be enrolled in the study. The potential participants will be screened based on the inclusion and exclusion criteria only after obtaining the written informed consent from the participants. Participants will be contacted telephonically by the recruiting/ screening department prior to the enrolment visit. Participants will be housed in a controlled environment maintained at a temperature of 23°C to 30°C and relative humidity of 40% RH to 60% RH. The participants will be instructed to visit the facility as per the visits below: Visit 1: Screening, ICD Obtained, Visit 2: Day 1: Participant’s reporting to facility in early morning, Euhydrated State Assessments and Dehydration Procedure, Day and Overnight housing. Participants will undergo a 24-hour controlled fluid-restriction phase, during which total fluid intake will be 750 to 1100 mL of water to induce dehydration while maintaining participant comfort. Day 2: Dehydration Confirmation, Intervention Phase, Follow-up Assessments, and End-of-Study Procedures, Discharge from the facility. Assessments of efficacy parameters will be done before administration of electrolyte drinks and after administration of electrolyte drinks at defined time points post-dosing: a. Salivary osmolality (SOsm) assessed by MX3 HTS Modified recovery scale for hydration by the Subjective Perception Questionnaire |