A Controlled Trial of Plantain Powder in Infantile Diarrhea

Study Overview
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Brief Summary
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Green banana has been traditionally used in diarrheal and other diseases. Recent studies have shown that green banana is beneficial in children with diarrhea. The purpose of this study is to try green banana in a portable, storable and dosable form in infants with diarrhea. Infants with diarrhea and meeting the inclusion criteria will receive either green banana powder or placebo (microcrystalline cellulose). Their response will be monitored for 10 days. The subjects, parents and researchers conducting the study will not know whether banana powder or placebo is being given to that particular subject (double blind randomized study). Two hundred patients will be enrolled in 24 months.

Official Title
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A Controlled Trail of Plantain Powder (Green Banana) in Infantile Diarrhea.

Conditions
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Diarrhea, Infantile

Intervention / Treatment
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* Dietary Supplement: Green banana powder
* Other: Microcrystalline cellulose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children between the ages of 5 months and 2 years of age admitted in the inpatient pediatric ward of Bhatpara Sub divisional Hospital. Infants with more than 3 stools/day which is more frequent than the usual bowel habit of the study subject The consistency of the stool is such that it takes the shape of the container into which it is put in. Duration of symptoms should be less than 14 days. - Exclusion Criteria: Children with bloody diarrhea Children with lethargy, fever or other signs of septicemia Children with shock. Children unable to take medications orally. Children with impaired consciousness. Children whose parents refuse permission to be included in the study. Children who are not usual residents of the area and will not be available for follow up. Children with chronic illnesses such as congenital heart disease, renal failure, chronic liver disease, chronic lung disease, inflammatory bowel disease, immune deficiency etc. -

Ages Eligible for Study
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Minimum Age: 5 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Green banana<br>Subjects receiving green banana powder. | Dietary Supplement: Green banana powder<br>* Green banana in powder form, 10 grams/ day for children below 10 kg, 20 grams for those weighing 10 Kg or more. Protocol Modified on Aug 5th 2009 to give 20 grams irrespective of age.<br>|
| Placebo Comparator: Placebo<br>Microcrystalline cellulose given as placebo | Other: Microcrystalline cellulose<br>* Microcrystalline cellulose 10 gm/ day for subjects below 10 kg in weight, 20 gms/ day for those weighing 10 Kg or more<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of stools per day. |  | Daily for 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the consistency of stool. |  | Daily for 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diarrhea, Plantain, Green banana, Infants, Children