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It is a study to compare the effectiveness and safety of oral and injectable steroids in systemic lupus erythematosus

A randomized open label trial comparing the efficacy and safety of oral Prednisolone versus intravenous Methylprednisolone pulse therapy in Systemic Lupus Erythematosus. - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063624
Enrollment
30
Registered
2024-03-05
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Health Condition 1: M329- Systemic lupus erythematosus, unspecified

Interventions

Intervention1: Oral Prednisolone: Systemic corticosteroids are considered as mainstay of therapy in SLE patients owing to their anti-inflammatory and immunosuppressive properties. Therapy will be star

Sponsors

IMS and SUM Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 years and above with SLEDAI score more than 10 fulfilling the EULAR criteria

Exclusion criteria

Exclusion criteria: 1. Patients on any treatment within last 3 months 2. Patients having features of other connective tissue diseases 3. Patients with other autoimmune conditions 4. Patients with pre-existing chronic renal failure, previous malignancy, and liver dysfunction, within six months prior to randomization. 5. Patients with previously documented severe toxicity to immunosuppressive drugs. 6. Patients with active acute or chronic infections. 7. Pregnancy and lactation.

Design outcomes

Primary

MeasureTime frame
Clinical assessment SLAM-R score Routine investigations (Complete Blood count, Liver function tests, Renal function tests, Urine routine microscopy)Timepoint: At Week 4, 8, 12, 16, 20, and 24.

Secondary

MeasureTime frame
Adverse effects due to the drugs if anyTimepoint: At the end of 24 weeks

Countries

India

Contacts

Public ContactDr Asritha C V V

IMS and SUM Hospital

pandamaitreyee@gmail.com7904072348

Outcome results

None listed

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