Health Condition 1: R197- Diarrhea, unspecified
Conditions
Interventions
Intervention1: Zinc Sulphate Dispersible Tablet 20 mg: Zinc Sulphate Dispersible Tablet 20 mg for 10 days.
Control Intervention1: NIL: NIL
Sponsors
Ipca Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subject with acute diarrhea (3 or more loose, liquid, or watery stools in past 24 hours). Subject must be healthy except for study-related disease condition in the opinion of the Investigator. Subjectâ??s parent/guardian should be ready to comply with the study procedures and adhere to the prohibitions and restrictions specified in the protocol. Subjectâ??s parent/guardian willing to sign an ICF indicating that they have understood the purpose of and procedures required for the study, and are willing for their childâ??s participation in the study.
Exclusion criteria
Exclusion criteria: Subject with pedal edema or who is severely dehydrated e.g. abnormally sleepy or lethargic, sunken eyes, drinking poorly or not at all, tachycardia, tachypnea, markedly reduced skin turgor; and require hospitalization. Subject with co-morbidity associated with excessive vomiting, e.g., whooping cough, pylorospasm, congenital pyloric stenosis, hiatus hernia, other obstructive defects of the gastrointestinal tract or a history of cowâ??s milk allergy, etc. Subject with any other known systemic complication, e.g. pneumonia, meningitis, sepsis, paralytic ileus, severe malnutrition, hypoglycemia, serum electrolyte disorders, seizure that require admission to the hospital. Subject with chronic or persistent diarrhea and dysentery, had developmental delay ( >1 year behind milestones), or having a birth defect or having a medical condition that could interfere with the ability to discriminate taste, e.g., common cold or a sinus or bronchial infection. Subject already on zinc supplementation, zinc fortified infant formulae, or receiving drugs that may inhibit zinc absorption such as iron supplements, penicillamine, sodium valproate, and ethambutol. Subject who has taken prescription drugs other than those prescribed for diarrhea during the preceding 24 hours. Subject with hypersensitivity to zinc or has known food or drug allergies to any of the constituents of the study drug product. Subject who has participated in any other clinical study within past 30 days or has participated in a similar study for zinc sulphate earlier.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the acceptability in terms of adherence of zinc sulphate dispersible tablets.Timepoint: 10 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the acceptability in terms of palatability of zinc sulphate dispersible tablets in children aged between 3 and 59 months with acute diarrhea. To compare the efficacy of zinc sulphate dispersible tablets in children aged between 3 to â?¤18 months and 18 to 59 months. To assess safety of zinc sulphate dispersible tablets in children aged between 3 and 59 months with acute diarrhea. Timepoint: 10 Days | — |
Countries
India, Malaysia
Contacts
Public ContactNitin Chandurkar
SIRO Clinpharm Pvt. Ltd
Outcome results
None listed