A prospective non-randomized controlled study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosus
- Conditions
- Systemic lupus erythematosus
- Registration Number
- ITMCTR2100005063
- Lead Sponsor
- Zhejiang Chinese Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- Not specified
1. Comply with the 2019 EULAR/ACR SLE classification standards;
2. Those who meet the TCM syndrome differentiation of heat toxin, blood stasis and kidney deficiency;
3.7 <= SLEDAI-2000 <=12 points and the current glucocorticoid dosage (calculated by prednisone) <= 1 mg/kg.d;
4. Those between the ages of 18 and 60;
5. Those who voluntarily participate in this trial and agree to sign the informed consent for entering the clinical research.
1. Neuropsychiatric lupus patients or lupus crisis patients;
2. Patients with severe diseases of target organs of various systems, mental illness, tumors and other diseases;
3. Patients who cannot tolerate the drug treatment of this study;
4. Pregnant and lactating women;
5. Patients who are participating in other clinical trials;
6. The researchers believe that other reasons are not suitable for clinical trials.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Systemic lupus erythematosus disease activity score;
- Secondary Outcome Measures
Name Time Method upusQoL quality of life;Number of severe infections;TCM syndrome score;Changes of biomarker indicators before and after treatment;