Trials / Terminated
TerminatedNCT00732732
A Controlled Trial of Plantain Powder in Infantile Diarrhea
A Controlled Trail of Plantain Powder (Green Banana) in Infantile Diarrhea.
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Augusta University · Academic / Other
- Sex
- All
- Age
- 5 Months – 24 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2008-09-01
- Primary completion
- 2010-01-01
- Completion
- 2010-01-01
- First posted
- 2008-08-12
- Last updated
- 2011-08-08
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT00732732. Inclusion in this directory is not an endorsement.