The efficacy of atorvastatin in treatment of Lupus

Comparison the efficacy of atorvastatin with placebo on disease activity in patients with systemic lupus erythematosus

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2012081110557N1

Enrollment

Registered

2012-10-02

Start date

2012-01-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Systemic Lupus Erythematosus. Systemic Lupus Erythematosus

Interventions

Intervention 1: Atorvastatin (20 mg/day) for 3 months. Intervention 2: Placebo (20mg/day) for 3 months.

Treatment - Drugs

Placebo

Atorvastatin (20 mg/day) for 3 months

Placebo (20mg/day) for 3 months

Eligibility

Sex/Gender

All

Age

16 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1- Diagnosis of systemic lupus Erythematosus according to American college of rheumatology criteria, 2- No allergy to atorvastatin, 3- No cyclophosphamide use in last three months, 4- No current use of prednisolone (=0.5mg/kg/day) or equivalent dose from other corticosteroids, 5- No current use of cyclosporine, 6- Serum creatinine 2x normal, 8- Unexplained myalgia during the study

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
SLEDAI-2K. Timepoint: Before and three months after intervention. Method of measurement: SLEDAI-2K checklist.	—

Secondary

Measure	Time frame
Anti-ds DNA. Timepoint: before and three months after intervention. Method of measurement: ELISA method.;C3. Timepoint: before and three months after intervention. Method of measurement: ELISA method.;C4. Timepoint: before and three months after intervention. Method of measurement: ELISA method.;CH50. Timepoint: before and three months after intervention. Method of measurement: Measurement of hemolytic activity of complement.;Serum Creatinine. Timepoint: before and three months after intervention. Method of measurement: autoanalyzer.;Alanine amino transferase. Timepoint: before and three months after intervention. Method of measurement: autoanalyzer.;Urine protein. Timepoint: before and three months after intervention. Method of measurement: Measurement of 24- hour urine protein.;Erythrocyte Sedimentation Rate. Timepoint: before and three months after intervention. Method of measurement: Westergreen method.;C reactive protein. Timepoint: before and three months after intervention. Method of measurement: ELISA method.;CBS. Timepoint: before and three months after intervention. Method of measurement: blood counting machine.;Triglyceride. Timepoint: before and three months after intervention. Method of measurement: Calorimetry.;Total Cholesterol. Timepoint: before and three months after intervention. Method of measurement: Calorimetry.;HDL. Timepoint: before and three months after intervention. Method of measurement: Calorimetry.;LDL. Timepoint: before and three months after intervention. Method of measurement: Calorimetry.	—

Measure

Time frame

Anti-ds DNA. Timepoint: before and three months after intervention. Method of measurement: ELISA method.;C3. Timepoint: before and three months after intervention. Method of measurement: ELISA method.;C4. Timepoint: before and three months after intervention. Method of measurement: ELISA method.;CH50. Timepoint: before and three months after intervention. Method of measurement: Measurement of hemolytic activity of complement.;Serum Creatinine. Timepoint: before and three months after intervention. Method of measurement: autoanalyzer.;Alanine amino transferase. Timepoint: before and three months after intervention. Method of measurement: autoanalyzer.;Urine protein. Timepoint: before and three months after intervention. Method of measurement: Measurement of 24- hour urine protein.;Erythrocyte Sedimentation Rate. Timepoint: before and three months after intervention. Method of measurement: Westergreen method.;C reactive protein. Timepoint: before and three months after intervention. Method of measurement: ELISA method.;CBS. Timepoint: before and three months after intervention. Method of measurement: blood counting machine.;Triglyceride. Timepoint: before and three months after intervention. Method of measurement: Calorimetry.;Total Cholesterol. Timepoint: before and three months after intervention. Method of measurement: Calorimetry.;HDL. Timepoint: before and three months after intervention. Method of measurement: Calorimetry.;LDL. Timepoint: before and three months after intervention. Method of measurement: Calorimetry.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr.Alimohammad Fatemi

Isfahan University of Medical Sciences and Health Services

a_fatemi@med.mui.ac.ir+98 31 1669 5414

Outcome results

None listed

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