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Comparing Dexamethasone and Prednisolone in Treating Low Platelet Counts in Children with Immune Thrombocytopenic Purpura: A Single-Center 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. - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/05/067294
Enrollment
92
Registered
2024-05-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D693- Immune thrombocytopenic purpura

Interventions

Intervention1: 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 cy

Sponsors

All India Institute of Medical Sciences, Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Improvement or resolution of thrombocytopeniaTimepoint: At baseline, day 1, day 2, day 3, day 4, day 5, day 6, day 7, 1 month and 6 months

Secondary

MeasureTime frame
a. To assess the likelihood of progression to persistent ITP in children treated with dexamethasone as compared to that with of prednisolone.Timepoint: 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 agentTimepoint: 6 months;To assess the need for platelet transfusion in both categoriesTimepoint: 6 months;To compare the steroid toxicity/adverse effects in both categoriesTimepoint: 6 months

Countries

India

Contacts

Public ContactUtkarsh Srivastava

All India Institute of Medical Sciences, Patna

cmkumar@aiimspatna.org8840756717

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026