A Controlled Trial of Plantain Powder in Infantile Diarrhea
|ClinicalTrials.gov Identifier: NCT00732732|
Recruitment Status : Terminated (Closed by US IRB due to lack of an adequate system for continuing review by the Indian IRB. No subjects enrolled in US.)
First Posted : August 12, 2008
Last Update Posted : August 8, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Diarrhea, Infantile||Dietary Supplement: Green banana powder Other: Microcrystalline cellulose||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Controlled Trail of Plantain Powder (Green Banana) in Infantile Diarrhea.|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||January 2010|
|Actual Study Completion Date :||January 2010|
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
- Frequency of stools per day. [ Time Frame: Daily for 10 days ]
- Change in the consistency of stool. [ Time Frame: Daily for 10 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732732
|Bhatpara Subdivisional Hospital|
|Bhatpara, West Bengal, India, N 24 pgs|
|Principal Investigator:||Tapas K Sabui, MD||NRS Medical College, Kolkata.|