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To compare the effect of 2 drugs namely Prednisolone and Dexamethasone while treating newly diagnosed ITP and to see if there is any correlation with T regulatory cell levels

Comparison of High Dose Dexamethasone Versus Prednisolone As First Line Treatment of Newly Diagnosed Immune Thrombocytopenia and Correlation with Regulatory T lymphocytes: A Randomized Controlled Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/08/020501
Enrollment
100
Registered
2019-08-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: 2 arms of drugs will be administered namely Prednisolone and High dose dexamethasone: High dose dexamethasone will be administered for 3 cycles consecutively at an interval of 2 weeks a

Sponsors

DrDebranjani Chattopadhyay
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of any age and of either gender who are newly diagnosed with immune thrombocytopenia as per the IWG guidelines and who are willing to give consent for the study

Exclusion criteria

Exclusion criteria: 1. Patients with chronic or relapsed or refractory immune thrombocytopenia 2. Patients who have already received therapy in the form of prior steroid therapy or immunomodulators within 3 months of enrollment. 3. Immune thrombocytopenia associated with secondary causes viz HIV, HCV, & malignancies

Design outcomes

Primary

MeasureTime frame
Bleeding Scores Platelet count improvement Time to response Complications with treatmentTimepoint: Bleeding Scores Platelet count improvement Time to response Complications with treatment—

Secondary

MeasureTime frame
Correlation with T regulatory cell percentage level in either treatment arm.Timepoint: At the onset of the disease prior to starting therapy—

Countries

India

Contacts

Public ContactDebranjani Chattopadhyay

AIIMS RISHIKESH

nath.uttam@gmail.com9433982756

Outcome results

None listed

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