Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04885049 |
| Other study ID # |
No.F.1-1/2015/ERB/SZABMU/556 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
February 1, 2022 |
Study information
| Verified date |
August 2021 |
| Source |
Shaheed Zulfiqar Ali Bhutto Medical University |
| Contact |
Nighat Haider, FCPS |
| Phone |
+92519107695 |
| Email |
nighathaider[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Children 1-12 years presenting/admitted with acute diarrhea will be enrolled in the study
after taking informed consent from the parents. Patients will be randomly allocated to two
equal groups. Group A (GA) will receive anti secretory 1.5mg/kg/dose, three doses in 24 hours
along with oral rehydration, while Group B (GB) will receive a single dose of bovine
immunoglobulins. Response to treatment will be assessed by recording the frequency of loose
stools after 72 hrs. Data will be collected through a structured proforma.
Description:
It is a randomized clinical trial that will be conducted at Children Hospital PIMS, Islamabad
over the period of 6 months. Sample size is calculated using World Health Organization (WHO)
calculator, keeping confidence level 95%, level of significance 5%, power of the test
80%,anticipated population proportion 1: 84%, anticipated population proportion 2: 93%, which
turn out to be 30.Consecutive non probability sampling technique will be used. Children 1-12
years both male and female visiting/admitted in Children Hospital PIMS with acute diarrhea of
less than 15 days duration will be enrolled in the study after taking informed consent from
the parents. Children requiring emergency resuscitation, having chronic diarrhea i-e more
than 15 days duration, having other comorbid conditions like heart, kidney and liver failure,
having metabolic disorder and who are allergic to egg or any of the contents will be excluded
from the study.
Child's name, age, sex will be recorded by the on duty doctor. Patients will be randomly
allocated to two equal groups. Group A (GA) will receive anti secretory 1.5mg/kg/dose three
doses per oral in 24 hours along with oral rehydration, while Group B (GB) will receive a
single dose of bovine colostrum and egg solids as 7 g of dry powder reconstituted in 30 mL of
water and taken orally once daily for 3 days along with oral rehydration. Response to
treatment will be assessed by recording the reduction in frequency of diarrheal episodes
after administration of drug and duration in which the diarrheal episodes were reduced. Data
will be collected through a structured proforma.
All data will be analyzed using latest SPSS version. Quantitative variables such as age, time
will be presented as means and standard deviations. Qualitative variables such as age groups,
sex, recurrence of seizures and efficacy will be measured as frequency and percentages.
Effect modifiers like age, gender will be controlled by stratification. Post stratification
chi-square test will be applied keeping p value ≤0.05 as significant.
