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CTRI Number  CTRI/2025/11/097649 [Registered on: 18/11/2025] Trial Registered Prospectively
Last Modified On: 18/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Observational, Single Center, Prospective 
Study Design  Other 
Public Title of Study   A study to determine if Electral-Z Plus, an oral rehydration drink containing zinc, is more effective than standard treatment in improving recovery from dehydration due to fever among participants. 
Scientific Title of Study   Effectiveness and safety of low osmolar oral rehydration solution plus zinc (Electral-Z Plus) in patients with fever-induced dehydration– A pilot study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No.-THBP22-003,Version: 3.1, Date: 20 JUN 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vijay N Kamale 
Designation  Head of Department of Pediatrics 
Affiliation  MGM Medical College and Hospital 
Address  Room No. 1, Department of Medicine, MGM Medical College and Hospital Sector 1 Kamothe Navi Mumbai 410209 Maharashtra India

Mumbai
MAHARASHTRA
410209
India 
Phone  9224475712  
Fax    
Email  drvijaynkamale@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kalpesh Dalvi 
Designation  Head Medical Services and Pharmacovigilance 
Affiliation  FDC Limited 
Address  FDC Limited FDC House C 11 and 12 Dalia Industrial Estate Oshiwara Village Off New Link Road Andheri West Mumbai 400 053

Mumbai
MAHARASHTRA
400102
India 
Phone  02226739347  
Fax    
Email  kalpesh.dalvi@fdcindia.com  
 
Details of Contact Person
Public Query
 
Name  Mr Gopal Kadam 
Designation  Senior Manager Medical Services and Pharmacovigilance 
Affiliation  FDC Limited 
Address  FDC Limited FDC House C 11 and 12 Dalia Industrial Estate Oshiwara Village Off New Link Road Andheri West Mumbai 400 053

Mumbai
MAHARASHTRA
400 053
India 
Phone  02226739152  
Fax    
Email  gopal.kadam@fdcindia.com  
 
Source of Monetary or Material Support  
FDC Limited 142-48, S. V. Road Jogeshwari (West) Mumbai - 400 102 Maharashtra India 
 
Primary Sponsor  
Name  FDC Limited 
Address  FDC House C11 and 12 Dalia Industrial Estate Oshiwara Village Off New Link Road Andheri West Mumbai 400 053 India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR VIJAY KAMALE  MGM Medical College and Hospital  Room No. 1, Department of Medicine, Sector 1, Kamothe
Mumbai
MAHARASHTRA 
09224475712

drvijaynkamale@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Research on Human Subjects (MGMIHS)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E860||Dehydration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Not Applicable  Not Applicable 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients of age groups between greater than or equal to 12 and less than 65 years
2. Patients with the onset of fever less than or equal to 72 hours
3. Patients with moderate dehydration based on the clinical
dehydration scale 
 
ExclusionCriteria 
Details  1. Patients with onset of fever greater than 3 days
2. Patients on any other oral rehydration salts
3. Patients with mild and severe dehydration, having a cumulative score less than 8 and greater than 14, respectively, on the clinical dehydration scale
4. Patients under treatment with other antioxidants (for example, vitamin C, vitamin E, beta carotene, and other related carotenoids,
along with the minerals selenium, zinc from other supplements, and manganese)
5. Patients who are hospitalized with intravenous (IV) rehydration therapy
6. Patients suffering from diarrhea without fever
7. Patients who are immunocompromised
8. Underlying severe chronic diseases, such as chronic kidney disease (CKD), chronic liver disease (CLD), congestive heart failure (CHF), severe respiratory diseases like chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, cancer, autoimmune diseases requiring immunosuppressive therapy, end stage neurological disorders, and severe malnutrition
9. Clinical signs of a coexisting severe acute systemic illness (meningitis, sepsis, pneumonia) and any clinical signs that may interfere with the treatment as per the investigators opinion
10. Patients with hypersensitivity to any ingredients of Electral Z plus or contraindicated to Electral Z plus 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate the effectiveness of low osmolar oral rehydration solution plus zinc (Electral-Z Plus) in patients with fever-induced dehydration compared to standard of care  1. Baseline and 1 Week 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the treatment outcomes of low osmolar oral rehydration solution plus zinc
(Electral-Z Plus) in patients with fever-induced dehydration compared to the
standard of care
2. To evaluate the safety of low osmolar oral rehydration solution plus zinc (Electral-Z Plus) in patients with fever-induced dehydration 
1. 6±2 days
2. 6±2 days 
 
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)   01/12/2025 
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="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
This is a prospective, observational, single-center, realworld study designed to evaluate the effectiveness and safety of a lowosmolar oral rehydration solution plus zinc (Electral Z Plus) in patients with fever induced dehydration. The study aims to assess improvement in dehydration symptoms and other clinical outcomes following treatment with Electral Z Plus compared to standard of care alone. The study hypothesis is that Electral Z Plus, when administered along with standard of care, will provide faster and more complete relief of dehydration symptoms in patients with fever-induced dehydration compared to standard of care alone.
The study will be conducted at one healthcare setup or clinic in India after obtaining Institutional Ethics Committee approval and written informed consent from all participants or their legally acceptable representatives. Separate informed consent documents are available for adults, parents or legal guardians, and adolescent participants.
A total of 60 patients aged 12 to 65 years with onset of fever within 72 hours and moderate dehydration based on the clinical dehydration scale will be enrolled. Patients will be divided in a 1 is to 1 ratio into two groups. Group I will receive standard-of-care plus Electral-Z Plus (n = 30, 15 pediatric and 15 adult patients), and Group II will receive standard-of-care alone (n = 30, 15 pediatric and 15 adult patients). Patients with onset of fever greater than three days, mild or severe dehydration, those on other oral rehydration salts or intravenous rehydration therapy, immunocompromised patients, or those with major chronic diseases or hypersensitivity to the study product will be excluded.
The study duration for each patient will be approximately 6 days plus or minus 2 days from baseline, with a follow up visit for clinical improvement and safety assessment. The overall study duration is expected to be about six to seven months.
The primary endpoint is the proportion of patients showing improvement in dehydration symptoms on the clinical dehydration scale at 6 days plus or minus 2 days from baseline. Secondary endpoints include complete resolution of dehydration symptoms, change in body weight, hospitalization rate, improvement in fever induced dehydration symptoms stratified by the number of tetra packs consumed, resolution of fever, mean change in body temperature, and frequency and severity of adverse events or serious adverse events.
All data will be captured using a structured data collection form and analyzed using R software. Continuous variables will be summarized as mean and standard deviation or median and range, and categorical variables as proportions. Statistical significance will be considered at p lesser than or equal to 0.05.

 
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