Trial | NCT00732732  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    green banana flour ...

  • Study Participants

    200
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.
Study Started
Sep 30
2008
Primary Completion
Jan 31
2010
Study Completion
Jan 31
2010
Last Update
Aug 08
2011
Estimate

Dietary Supplement Green banana powder

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.

Other Microcrystalline cellulose

Microcrystalline cellulose 10 gm/ day for subjects below 10 kg in weight, 20 gms/ day for those weighing 10 Kg or more

Green banana Experimental

Subjects receiving green banana powder.

Placebo Placebo Comparator

Microcrystalline cellulose given as placebo

Criteria 

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.

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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.

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No Results Posted