| CTRI Number |
CTRI/2010/091/001227 [Registered on: 05/10/2010] |
| Last Modified On: |
|
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
|
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
hypertonic saline in bronchiolitis |
|
Scientific Title of Study
|
To compare the effect of nebulised 3% hypertonic saline (HS) with nebulised 0.9% normal saline in treatment of bronchiolitis in hospitalized children by a hospital based randomized, double-blind control 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 |
dr. b. s. sharma |
| Designation |
|
| Affiliation |
|
| Address |
b-2, new heera bagh flats,near nurse's hostel, sms hospital campus, jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
01412563000 |
| Fax |
|
| Email |
drbssharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr. b. s. sharma |
| Designation |
|
| Affiliation |
sms hospital |
| Address |
b-2, new heera bagh flats,near nurse's hostel, sms hospital campus, jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
01412563000 |
| Fax |
|
| Email |
drbssharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
dr. b. s. sharma |
| Designation |
|
| Affiliation |
|
| Address |
b-2, new heera bagh flats,near nurse's hostel, sms hospital campus, jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
01412563000 |
| Fax |
|
| Email |
drbssharma@gmail.com |
|
|
Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
self |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dr B. S. Sharma |
s ms hospital japur |
j k lone hospital , j ln marg , jaipur,-302004
Jaipur
RAJASTHAN |
0141-2563000
drbssharma@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sms hospital ethics committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
bronchiolitis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
hypertonic saline nebulisation |
as per study protocol |
| Comparator Agent |
normal saline nebulisation |
as per study protocol |
|
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Children with bronchiolitis (defined by prodrome of upper respiratory tract infection, including rhinorrhea, cough, and sometimes low-grade fever, which progresses to lower respiratory tract involvement, paroxysmal cough and dyspnoea), with pulmonary score index >0 and ≤ 6 |
|
| ExclusionCriteria |
| Details |
previous episode of wheezing;
chronic cardiopulmonary disease;
critical illness at presentation requiring admission to intensive care; or ventilatory support;
the use of nebulised HS within the previous 12 hours;
pulmonary score index > 6;
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| imrovement in psi score |
when psi score less than 3 |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in hospital stay |
time taken to achieve study end points |
|
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Target Sample Size
|
Total Sample Size="250"
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" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/10/2009 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
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 study is randomised, double blind, conrolled trial comparing hypertonic saline verses normal saline in treatment of bronchiolitis in moderately ill hospitalised children. primary outcome measured will be improvement in psi score and secondary outcome will be reduction in hospital stay. |