Health Condition 1: E860- Dehydration
Conditions
Interventions
Intervention1: Not Applicable: Not Applicable
Intervention2: NA: NA
Intervention3: Nil: Nil
Intervention4: Nil: Nil
Control Intervention1: Not Applicable: Not Applicable
Sponsors
FDC Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 careTimepoint: 1. Baseline and 1 Week | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 dehydrationTimepoint: 1. 6 2 days 2. 6 2 days | — |
Countries
India
Contacts
Public ContactMr Gopal Kadam
FDC Limited
Outcome results
None listed