The Safety and Efficacy of Zishenqing in Subjects With Active Systemic Lupus Erythematosus

Inclusion Criteria:

1. Patients who qualify for the diagnosis of systemic lupus erythematosus according tothe American college of rheumatology's 1997 revised classification criteria forsystemic lupus erythematosus;

2. For inpatient or out-patient with good compliance, sign the informed consent beforethe test;

3. Sledai score during screening period≤10;

4. Maintain a stable standard treatment regimen for at least 30 days before the first day (that is, the date of administration of the intervention drug). Standard treatmentregimens refer to the stable use of any of the following (alone or in combination):corticosteroids, hydroxychloroquine, non-steroidal anti-inflammatory drugs, otherimmunosuppressants or immunomodulators (including azathioprine, mycophenolate ester,cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine);

Exclusion Criteria:

1. Severe lupus nephritis requiring hemodialysis or high-dose glucocorticoid treatment inthe last 2 months;

2. Central nervous system diseases (including epilepsy, psychosis, organic encephalopathysyndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis)caused by SLE or non-SLE in the last 2 months;

3. Patients with severe heart, liver and kidney diseases and disease history of importantorgans, blood and endocrine system; Evaluation criteria of severity:

4. Alanine aminotransferase(ALT) and Aspartate aminotransferase(AST)≥3 times theupper limit of normal;

5. Glomerular filtration rate(GFR)<30ml/min;

6. White Blood Cell(WBC)<2.0×10^9/l;

7. Platelet(PLT)<50×10^9/l;

8. Immunodeficiency, uncontrolled infection and active or recurrent peptic ulcer;

9. Pregnant and lactating women;

10. Anaphylaxis: allergic to traditional Chinese medicine;

11. The investigator considered it inappropriate to participate in this study;

12. Participate in other clinical trials during the screening period.