An interventional study of Racecadotril and DiaResQ Children's Powder for Suspension in Diarrhea, sponsored by Shaheed Zulfiqar Ali Bhutto Medical University. Status unknown. Open to participants aged 1 Year to 12 Years. Per ClinicalTrials.gov, last updated 2021-08-26.
Sponsored by Shaheed Zulfiqar Ali Bhutto Medical University · Not applicable, Interventional, and Treatment
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.
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.
852 studies on the registry are indexed under Diarrhea; 78 are open to participants now.
This study's planned enrollment of 60 is below the median of 136 across 713 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Shaheed Zulfiqar Ali Bhutto Medical University is the lead sponsor of 32 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Group A (GA) will receive anti secretory 1.5mg/kg/dose three doses per oral in 24 hours for 3 days along with oral rehydration
Drug: Racecadotril
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
Drug: DiaResQ Children's Powder for Suspension
Anti secretary
oral immunoglobulins
frequency of diarrheal episodes
reduction in frequency of diarrheal episodes after administration of drug
Time frame: 24 to 72 hours
No study locations are listed for this record.
Plan to share: Yes — If somebody wants the IPD they can email the principal investigator and it will be provided after the publication
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Shaheed Zulfiqar Ali Bhutto Medical University