| 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
|
|
|
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
|
|
|
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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