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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 March 2021 |
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Main ID: |
NCT03366740 |
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Date of registration:
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05/11/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Green Banana (GB) Mixed Diet in the Management of Persistent Diarrhea (PD)
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Scientific title:
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Efficacy of GB Mixed Full Strength Rice Suji, and Full Strength Rice Suji Alone Compared to 3/4th Strength Rice Suji in the Management of PD in Children Aged > 6 Months to 36 Months: an Open-labeled Randomized Controlled Clinical Trial |
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Date of first enrolment:
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December 7, 2017 |
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Target sample size:
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135 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03366740 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Bangladesh
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Contacts
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Name:
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Monira Sarmin, MBBS |
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Address:
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Telephone:
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01718596947 |
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Email:
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drmonira@icddrb.org |
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Affiliation:
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Name:
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Monira Sarmin, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical officer, ICU |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children aged > 6 to 36 months, having diarrhea for 14 days or more (up to 29 days)
either at admission or developed at some point during their treatment period in
hospital
- Children able to take oral feeds at the time of randomization
Exclusion Criteria:
- Children whose parents/care givers do not provide consent
- Growth of Shigella, Salmonella or Cholera in rectal swab culture
- Children having WLZ/WHZ < -5 SD or +++ edema
- The children presented with septic shock, convulsion or any other illness that needs
ICU support during the admission
- Birth defect like complex congenital heart diseases, cleft lip and cleft palate, Down
syndrome and cerebral palsy and others that may itself cause digestive problem or
failing to thrive
- Children diagnosed as having apparent or known tuberculosis or HIV or chronic (> 30
days)/organic diarrhea (where the cause is known e.g. crohn's disease, ulcerative
colitis, celiac disease etc.)
Age minimum:
6 Months
Age maximum:
36 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Persistent Diarrhea
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Intervention(s)
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Other: 3/4th strength rice suji
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Other: Full strength rice suji Alone
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Other: GB mixed full strength rice suji
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Primary Outcome(s)
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By day 5, percentage of children recovered from diarrhea by the study diets
[Time Frame: 5 days]
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Secondary Outcome(s)
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By day 7, percentage of children recovered from diarrhea by the study diets
[Time Frame: 7 days]
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Number of hospital acquired infection (HAI) in different study diet groups
[Time Frame: 7 days]
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Frequency of stool in different days in different study diet groups
[Time Frame: 7 days]
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Consistency of stool in different days in different study diet groups
[Time Frame: 7 days]
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Rate of relapse within 14 days follow up
[Time Frame: 14 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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