| CTRI Number |
CTRI/2024/05/067294 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Dexamethasone and Prednisolone in Treating Low Platelet Counts in Children with Immune Thrombocytopenic Purpura: A Single-Center Study |
|
Scientific Title of Study
|
Assessment of efficacy of dexamethasone as compared to prednisolone as first line oral steroid for remission of thrombocytopenia in acute immune thrombocytopenic purpura in children, a single centered open label randomized control 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 |
Utkarsh Srivastava |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
D2A Paediatrics ward, department of paediatrics, second floor, IPD building, AIIMS, Patna
Patna
BIHAR
801507
India |
| Phone |
8840756717 |
| Fax |
|
| Email |
utkarshsrivastava5199@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Chandra Mohan Kumar |
| Designation |
Professor and Head |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Paediatrics, second floor, IPD building, AIIMS, Patna
Patna
BIHAR
801507
India |
| Phone |
8840756717 |
| Fax |
|
| Email |
cmkumar@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Utkarsh Srivastava |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, Patna |
| Address |
D2A Paediatrics ward, department of paediatrics, second floor, IPD building, AIIMS, Patna
Patna
BIHAR
801507
India |
| Phone |
8840756717 |
| Fax |
|
| Email |
utkarshsrivastava5199@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Patna, Bihar, India, Pin code: 801507 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Patna |
| Address |
AIIMS, Phulwarisharif, Patna, Bihar. Pin code: 801507 |
| 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 |
| Utkarsh Srivastava |
All India Institute of Medical Sciences, Patna |
D2A Paediatrics Ward Department of Paediatrics Second floor IPD building AIIMS Phulwarisharif Patna Pin code 801507
Patna
BIHAR |
8840756717
utkarshsrivastava5199@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D693||Immune thrombocytopenic purpura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone |
Dexamethasone will be gievn at a dose of 24 mg/m2 (maximum 40 mg) divided into two doses for 1 cycle and if required 2 or 3 cycles if no response noted in 1 cycle or 2 cycles to the intervention group |
| Comparator Agent |
Prednisolone |
Prednisolone will be given at a dose of 2 mg/kg/day divided into two doses for 14 days, followed by 1 mg/kg/day for 7 days, and then 0.5 mg/kg/day for 7 days. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ITP visiting OPD/admitted in Paediatrics ward of AIIMS Patna who are between 1 to 18 years of age and have not received steroids in past 1 month and require treatment as per the protocol |
|
| ExclusionCriteria |
| Details |
1. Patients with inherited platelet disorders (Bernard-Soulier syndrome, Glanzmann thrombasthenia, etc.)
2. Patients with known rheumatological diseases already on steroids or steroid sparing drugs (SLE, APLA, etc.)
3. Patients with known malignancy receiving chemotherapy and/or radiotherapy.
4. Patients of aplastic anemia
5. Patients of chronic or persistent ITP
6. Patients taking antiplatelet drugs.
7. Patients who received steroid(s) or IVIG or platelet transfusion(s) prior to presenting to AIIMS Patna.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement or resolution of thrombocytopenia |
At baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7, 1 month and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| a. To assess the likelihood of progression to persistent ITP in children treated with dexamethasone as compared to that with of prednisolone. |
6 months |
| b. Time spent under the danger zone of risk of bleeding i.e., platelet count less than 20,000/mm3 during treatment with either agent |
6 months |
| To assess the need for platelet transfusion in both categories |
6 months |
| To compare the steroid toxicity/adverse effects in both categories |
6 months |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
24/05/2024 |
| 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) |
Open to Recruitment |
|
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
Modification(s)
|
The study has been proposed to be done by the Department of Paediatric Medicine. Purpose of the study is to determine the efficacy of dexamethasone when compared to prednisolone as a first line steroid to be used in patients of acute ITP in children. Once the diagnosis of ITP has been established a baseline CBC will be done to look for platelet counts and other haematological parameters. Children will then be allotted a group by randomisation using an opaque sealed enveloped technique and will be divided in group A (will receive Dexamethasone 40 mg for a total duration of 4 days) and group B (will receive Prednisolone at 2 mg/kg/day for 14 days and then taper over next 2 weeks). Child will be monitored for bleeding manifestations. A repeat CBC will be done as per clinical indication and at 1 and 3 months following the initial presentation. Then the child will be evaluated for complete response, response and no response. Then using relevant statistical test, the outcome will be inferred. The interested subjects who are willing to participate in the research will be given the Participant Informed consent form (PICF) which they are abide to fill after reading. Further, the data will be captured in a Data capture sheet. The data will be collected, assembled and analysed using Statistical Product and Service Solutions (SPSS version 22) software package for Windows/Mac, Student Edition. |