Health Condition 1: M321- Systemic lupus erythematosus withorgan or system involvement
Conditions
Interventions
Intervention1: Metformin + standard of care: Metformin Oral 500mg twice daily for 6 months + Standard of care (steroid with immunosuppressive agent as per treating physcians discretion)
Control Interv
Sponsors
West Bengal Department of Science and Technology and Biotechnology
Eligibility
Inclusion criteria
Inclusion criteria: 1.Fulfilling 2019 ACR EULAR Classification criteria of SLE 2.Patients with proliferative lupus nephritis Class III and IV 3.24 hours urine protein more than or equal to 500mg per day
Exclusion criteria
Exclusion criteria: 1. Smokers 2. Suffering from human immunodeficiency infection, chronic hepatitis C or B infection, heart failure, cirrhosis liver, diabetes mellitus, severe renal disease eGFR less than or equal to 45ml per min per 1.73 sq m BSA 3.Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in SLEDAI-2K scoreTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in SLEDAI-2K scoreTimepoint: 3 months;Renal relapseTimepoint: 3 and 6 months;Frequency and severity of adverse eventsTimepoint: 6 months;Change in Interferon levelsTimepoint: 3 and 6 months;Status of mitochondrial ROSTimepoint: 3 and 6 months;Change in serological markers of disease activityTimepoint: 3 and 6 months;Proportion of patients achieving prednisolone less than 7.5mg/dayTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Pradyot Sinhamahapatra
IPGMER
Outcome results
None listed