| CTRI Number |
CTRI/2024/10/075351 [Registered on: 15/10/2024] Trial Registered Prospectively |
| Last Modified On: |
14/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare Dexamethasone and Prednisolone in acute attack of bronchial asthma in children |
|
Scientific Title of Study
|
Comparison of oral Dexamethasone and Prednisolone in Acute Bronchial Asthma: A Randomized Controlled Trial |
| 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 Sajal Choudhary |
| Designation |
DNB, Paediatrics |
| Affiliation |
Government Multi specialty Hospital, sector 16 , Chandigarh |
| Address |
Department of pediatrics, Government Multispecialty Hospital, sector 16, Chandigarh
Chandigarh
CHANDIGARH
160015
India |
| Phone |
8005921471 |
| Fax |
|
| Email |
sajals076@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeraj Dhawan |
| Designation |
senior medical officer |
| Affiliation |
Government Multi specialty Hospital, sector 16 , Chandigarh |
| Address |
Department of pediatrics, Government Multispecialty Hospital, sector 16, Chandigarh
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9815629496 |
| Fax |
|
| Email |
ndhawan_6144@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeraj Dhawan |
| Designation |
senior medical officer |
| Affiliation |
Government Multi specialty Hospital, sector 16 , Chandigarh |
| Address |
Department of pediatrics, Government Multispecialty Hospital, sector 16, Chandigarh
Chandigarh
CHANDIGARH
160015
India |
| Phone |
9815629496 |
| Fax |
|
| Email |
ndhawan_6144@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Multispecialty Hospital, Sector 16, Chandigharh, India, Pincode:160015 |
|
|
Primary Sponsor
|
| Name |
Department of Pediatrics Government Multi specialty hospital Chandigarh |
| Address |
Government Multispecialty Hospital, Sector 16, Chandigarh, India, Pincode:160015
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sajal Choudhary |
Government Multispecialty Hospital |
Advanced Pediatrics Centre,
Room no. 101 (Pediatrics emergency), Government Multispecialty Hospital, Sector 16, Chandigarh
Chandigarh
CHANDIGARH |
8005921471
sajals076@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Thesis Committee Government Multispecialty Hospital, Sector 16, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J459||Other and unspecified asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone |
0.6 mg/kg/day, max dose 15 mg, for 2 days, per oral |
| Comparator Agent |
Prednisolone |
2 mg/Kg/day, maximum dose 60 mg, for 5 days, , per oral
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children between the ages of 2-12 years hospitalized with at least one previous exacerbation of wheeze or a known case of asthma. |
|
| ExclusionCriteria |
| Details |
1. Contraindication for use of dexamethasone or prednisolone.
2. Significant medical comorbidity: Congenital and acquired heart disease, chronic lung disease, tuberculosis, cholestatic jaundice.
3. Life threatening exacerbation requiring PICU admissions.
4. Children already enrolled in the study and presenting within 60 days of discharge from hospital.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of improvement in PRAM score |
At admission, 12 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of length of hospital stay between 2 groups. |
0 to 14 days |
| Comparison of recurrence of symptom. |
on day 7 after discharge |
| Need for additional steroid in dexamethasone group. |
within 24 hours |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
01/11/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Comparison of oral Dexamethasone and Prednisolone in Acute Bronchial Asthma in children: A Randomized Controlled Trial. Data will be collected during hospitalization period and patient will; be reviewed after 7 days. The patients will receive either oral dexamethasone for 2 days or oral prednisolone for 5 consecutive days in addition to the standard treatment. Length of hospital stay and number of Emergency department revisits within next 7 days after discharge will be compared between two groups. |