Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-01-02 @ 12:56 AM
Study NCT ID:
NCT00732732
Status:
TERMINATED
Last Update Posted:
2011-08-08
First Post:
2008-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Controlled Trial of Plantain Powder in Infantile Diarrhea
Sponsor:
Augusta University
Organization:
Study Overview
Official Title:
A Controlled Trail of Plantain Powder (Green Banana) in Infantile Diarrhea.
Status:
TERMINATED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed by US IRB due to lack of an adequate system for continuing review by the Indian IRB. No subjects enrolled in US.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: