A Controlled Trial of Plantain Powder in Infantile Diarrhea
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.
|Diarrhea, Infantile||Dietary Supplement: Green banana powder Other: Microcrystalline cellulose|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Official Title:||A Controlled Trail of Plantain Powder (Green Banana) in Infantile Diarrhea.|
- Frequency of stools per day. [ Time Frame: Daily for 10 days ]
- Change in the consistency of stool. [ Time Frame: Daily for 10 days ]
|Study Start Date:||September 2008|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Experimental: Green banana
Subjects receiving green banana powder.
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.
Placebo Comparator: Placebo
Microcrystalline cellulose given as placebo
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00732732
|Bhatpara Subdivisional Hospital|
|Bhatpara, West Bengal, India, N 24 pgs|
|Principal Investigator:||Tapas K Sabui, MD||NRS Medical College, Kolkata.|