| CTRI Number |
CTRI/2008/091/000255 [Registered on: 05/01/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
|
A clinical trial to study the effect of Saccharomyces boulardii in acute childhood diarrhoea |
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Scientific Title of Study
|
"Efficacy and safety of Saccharomyces boulardii in acute childhood diarrhoea:adouble blinded randomised controlled trial ". |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
mohd. mushir reyaz |
| Designation |
|
| Affiliation |
|
| Address |
junio residentr,dept. of pediatric
jnmch,amu
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
09997497934 |
| Fax |
|
| Email |
mushir_reyaz@yahoo.com |
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Details of Contact Person
Scientific Query
|
| Name |
dr.seema alam |
| Designation |
|
| Affiliation |
|
| Address |
reader,dept. of pediatric
jnmch,amu
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
09359527775 |
| Fax |
|
| Email |
seema_alam@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr.seema alam |
| Designation |
|
| Affiliation |
|
| Address |
reader,dept. of pediatric
jnmch,amu
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
09359527775 |
| Fax |
|
| Email |
seema_alam@hotmail.com |
|
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Source of Monetary or Material Support
|
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Primary Sponsor
|
| Name |
mohd mushir reyaz |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
|
| Name |
Address |
| dr.seema alam |
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Countries of Recruitment
|
India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| mohd mushir reyaz |
Pediatric ward(ward :16) |
Dept of Pediatric,jnmc, amu-202002
Aligarh
UTTAR PRADESH |
09997497934
mushir_reyaz@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee ,jnmc , amu |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
acute childhood diarrhoea, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
placebo |
5 gm BD,3 D or till recovery, whichever is earlier |
| Intervention |
Saccharomyces boulardii |
250 mg,BD for 3D or till recovery whichever is earlier |
|
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Inclusion Criteria
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| Age From |
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| Age To |
|
| Gender |
|
| Details |
children age 3mths-5yrs with acute diarrhoea |
|
| ExclusionCriteria |
| Details |
severe malnutrition ,systemic illness,encephalopathy,convulsion,feature of immunodeficiency,use of IV antibiotics |
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Method of Generating Random Sequence
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Stratified block randomization |
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Method of Concealment
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Pre-numbered or coded identical Containers |
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Blinding/Masking
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Participant and Outcome Assessor Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| duration of diarrhoea |
3 consecutive semi-formed stool or no stool in last 12 hours |
|
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Secondary Outcome
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| Outcome |
TimePoints |
| rehydration time ,ORS consumed,frequency of vomiting and diarrhoea,adverse drug reaction to S.boulardii |
3 consecutive semiformed stool or no stool in last 12 hours |
|
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Target Sample Size
|
Total Sample Size="200"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
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Phase 3/ Phase 4 |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/06/2008 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
this is an ongoing double blinded randomized controlled clinical trial to see the efficacy and safety of Saccharomyces boulardii(250 mg BD for 3days or till recovery whichever is earlier) in acute childhood diarrhoea.it is being conducted at pediatric ward ,jnmc,amu,aligarh ,india.primary outcome variable is duration of diarrhoea .The secondary outcome variable are rehydration time,frequency of loose stool&vomiting,ORS consumed,adverse drug reaction to S.boulardii |