| CTRI Number |
CTRI/2024/04/065551 [Registered on: 10/04/2024] Trial Registered Prospectively |
| Last Modified On: |
06/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of supplementation of cooked green banana in management of acute diarrhea in under-5 children |
|
Scientific Title of Study
|
Role of green banana in management of acute diarrhea in under-5 children |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sudipto Paul |
| Designation |
Senior Resident |
| Affiliation |
Burdwan Medical College |
| Address |
Roomn no-7,3rd floor, Deptt of Pediatrics, Burdwan Medical College, Burdwan
Barddhaman
WEST BENGAL
713104
India |
| Phone |
9475501788 |
| Fax |
|
| Email |
sudiptopaul165854@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudipto Paul |
| Designation |
Senior Resident |
| Affiliation |
Burdwan Medical College |
| Address |
Room no-7, 3rd floor, Deptt of Pediatrics, Burdwan Medical College, Burdwan
Barddhaman
WEST BENGAL
713104
India |
| Phone |
9475501788 |
| Fax |
|
| Email |
sudiptopaul165854@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kamirul Islam |
| Designation |
Consultant |
| Affiliation |
Katwa SDH |
| Address |
2nd floor, Deptt of Pediatrics,
katwa SDH, Burdwan
3rd floor, Deptt of Pediatrics, Burdwan Medical College, Burdwan
Barddhaman
WEST BENGAL
713130
India |
| Phone |
8972360456 |
| Fax |
|
| Email |
kamirul.islam7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deptt of Pediatrics, Burdwan Medical College, West Bengal, India, PIN-713104 |
|
|
Primary Sponsor
|
| Name |
Burdwan Medical College |
| Address |
Baburbag, Burdwan, WB
India, PIN-713104 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sudipto Paul |
Burdwan Medical College |
Ground Floor and 3rd floor, Deptt of Pediatrics, Burdwan Medical College
Barddhaman
WEST BENGAL |
9475501788
sudiptopaul165854@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Burdwan Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R197||Diarrhea, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cooked green banana |
Cooked green banana 100 g, 200 g and 300 g respectively for children 1 year, 1-3 year, and 3-5 year for 5 days in addition to standard treament [Zinc 20mg/day, ORS, and Intravenous fluid for children with severe dehydration]. The standard management is continued till the child is diarrhea-free. |
| Comparator Agent |
Standard treatment |
Standard treatment for diarrhea [zinc, ORS and intravenous fluid for children with severe dehydration]. The treatment is continued till the child is diarrhea free. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
All the children with acute watery diarrhea were approached for inclusion in the study. |
|
| ExclusionCriteria |
| Details |
Children with invasive diarrhea, Whose parents denied consents, Children with major systemic illness. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of diarrhea |
2 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of children recovered from diarrhea |
3rd and 7th day |
| Required hospitalisation/Increased grade of dehydration |
Total duration of diarrhea |
| Proportion of children developed persistent diarrhea |
14 th day |
| Incidence rate of diarrhea in follow up period |
Till 1 year |
|
|
Target Sample Size
|
Total Sample Size="318"
Sample Size from India="318"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
22/04/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diarrhea is a major cause of under-5 mortality in Indian children. Green banana is useful as home-remedy. In this trial children with acute diarrhea will be divided in two groups- Study and control group. Children of study group will receive green banana (amount according to age) along with standard treatment. Children of control group will receive standard management only. Standard management includes ORS, zinc and intravenous fluid in children with severe dehydration. Duration of diarrhea will be primary outcome. |