Systemic Lupus Erythematosus
Conditions
Interventions
Observation group:On the basis of conventional treatment, Qihuang Jianpi Zishen granule was added. The conventional treatment included prednisone 0.5-1.0 mg/kg·d, hydroxychloroquine sulfate 0.2 g twic
Control Group:Prednisone 0.5-1.0 mg/kg·d, hydroxychloroquine sulfate 0.2 g twice daily, mycophenolate mofetil capsule 0.5 g twice daily
Sponsors
The First Affiliated Hospital of Anhui University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Based on the 2019 EULAR/ACR classification criteria for systemic lupus erythematosus (SLE); (2) Patients diagnosed with spleen-kidney deficiency syndrome according to traditional Chinese medicine (TCM) differentiation; (3) Age =18 years and =65 years; (4) SLEDAI-2000 score between 5 and 9 points (5 points = SLEDAI-2000 = 9 points); (5) Participants who have signed an informed consent form and voluntarily agree to participate.
Exclusion criteria
Exclusion criteria: (1) Individuals with allergies to the investigational drug; (2) Individuals with fundus and visual field abnormalities or arrhythmias; (3) Individuals with other rheumatic or immunological diseases; (4) Individuals with severe infections; (5) Individuals with a positive Coombs test; (6) Individuals who have used biologics or immunosuppressants within the past 12 weeks (excluding hydroxychloroquine sulfate); (7) Individuals who are pregnant, breastfeeding, or have mental illnesses.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score;C3;C4;ANA;ds DNA;IgA;IgG;IgM;Blood Routine;24hPRO;Scr;eGFR;ACR;TPCR;Urine protein series;Interleukin-6 (IL-6);Interleukin-10 (IL-10);Tumor Necrosis Factor-alpha (TNF-a);Interferon-gamma (IFN-?);Toll-like receptor 4 (TLR4);Nuclear Factor kappa-B p65 (NF-?B p65);Beclin-1;Sequestosome-1 (p62);Nephrin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life Assessment;Depression Self-Rating Scale;Anxiety Self-Rating Scale; | — |
Countries
China
Contacts
Public ContactLi Ming
The First Affiliated Hospital of Anhui University of Chinese Medicine
Outcome results
None listed