Incidence of Abdominal Pain Clinical Trial
Official title:
Comparing the Efficacy of Different Zinc Formulations in the Treatment of Acute Diarrhea Among Young Children at Hospital Based Setting in Pakistan
This project is aimed to evaluate the efficacy of two different zinc formulations (dispersible Zinc tablets versus Zinc suspension) for the treatment of acute diarrhea in hospital based settings. Additionally we intend to compare the effectiveness of treatments of different groups on the basis of usage of Zinc in the treatment of diarrhoea, and to monitor additional treatment components such as ORS, antibiotic usage rates.
This will be an open randomized trial in children designed to measure the impact and
efficacy of daily zinc administration. There will be two groups in the study, one group will
receive Zinc in the form tablets, other will receive in the form of suspension, both of
these groups will also receive recommended treatment of diarrhea as per WHO protocol and
these groups will be enrolled from the patients admitting in the Paediatric Unit of Civil
Hospital, Hyderabad and NICH, Karachi with the complain of acute diarrhoea.
The intervention study will be undertaken in hospital based settings. A total recruitment of
300(150 each in each group) has been targetted during the study duration. The duration of
this study shall be 9 months.
A brief history will be taken regarding the current illness and will be noted down in the
specific forms. After the history the patient will be completely examined by the duty
doctors, examination will emphasize of the vitals, status of dehydration and anthropometry.
Patient will then be randomized in one of the groups and the procedure of using Zinc tablets
or suspension will be explained to the mother or caretaker.The patient will be advised
treatment according to the general condition and state of the dehydration and general
health. All treatments will be noted down in the specific forms to have a record of what
have been given to the patient and to keep the record of fluid intake. Stool samples for the
detailed report and culture and sensitivity will be collected & sent to have the information
regarding the status of stool and any isolated organism.
Follow-ups
- The patients will be followed & examined thoroughly every 8 hourly till the time of
discharge by a trained RMO.
- At each follow up, details of illness characteristics, including the number and
character of stools and vomiting, will be obtained.
- Information regarding the associated symptoms including fever, abdominal pain
distension and dysentery will be obtained. Hydration status, vitals and weight will
also be assessed.
- RMO will record about the proper dosages of zinc and confirm that weather or not
patient is taking his medications during every follow up
- RMO will also document the recovery of diarrhea in terms of reduction in frequency and
duration of diarrhoea and all the information will be noted in the assigned follow up
forms.
- Any adverse effect of the associated with the Zinc will also be recorded.
- Compliance will be measured by reported intake and by measuring the remaining volume of
syrup in the returned bottles and number of tablets used in the blisters.
- At the time of discharge a discharge summary form is also filled by RMO
- The patients who will be discharged will be followed at home for a total of two weeks
of illness.
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment