Comparing the Efficacy of Different Zinc Formulations in the Treatment of Diarrhea
Condition: Incidence of Acute Diarrhea; Incidence of Abdominal Pain
MeSH terms: Diarrhea; Abdominal Pain
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Zinc Sulphate; Zinc Sulphate
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg per day, Zinc Sulphate tablet has been given to subjects.; 20 mg per day of Zinc Sulphate in suspension form has been given to subjects.
Other intervention name(s): Zincol; Zincat
Intervention MeSH terms: Zinc; Zinc Sulfate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diarrhea; Zinc Sulphate; Efficacy