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A clinical trial to compare the effect of drug, methylprednisolone with dexamethasone in patients with immune thrombocytopenia

Randomised controlled trial of high dose dexamethasone and methylprednisolone in Immune Thrombocytopenia - HDMI

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035392
Enrollment
60
Registered
2021-08-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-08-21

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 Health Condition 2: D693- Immune thrombocytopenic purpura

Interventions

Intervention1: methylprednisolone: intravenous methylprednisolone [15mg/kg (maximum 1g) infusion over 2-3 hours for three days] followed by oral prednisolone (1 mg/kg/day daily) up to six weeks Contro

Sponsors

Kundan Mishra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with diagnosis of ITP as per IMWG criteria 2. Patients of ITP who require corticosteroid therapy

Exclusion criteria

Exclusion criteria: 1. Patients age 2. Patients who denied to give consent. 3. Patients of secondary ITP. 4. Patients not willing to receive any therapy 5. Patients of ITP who requires observation or any other drug except corticosteroid and immunoglobulin 6. Patients who are allergic to corticosteroids 7. Patients who can not be followed up for at least two-month after beginning of the study.

Design outcomes

Secondary

MeasureTime frame
To estimate and compare adverse events associated with methylprednisolone in ITPTimepoint: six week;To estimate and compare the response rate (CR, OR) of methylprednisolone in ITPTimepoint: six-week

Primary

MeasureTime frame
To estimate and compare the changes in the platelet count after methylprednisoloneTimepoint: One-week, two-week, four-week, six-week

Countries

India

Contacts

Public ContactKundan Mishra

Army Hospital (Research and Referral)

mishrak20@gmail.com

Outcome results

None listed

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