Status:
UNKNOWN
The Safety and Efficacy of Zishenqing in Subjects With Active Systemic Lupus Erythematosus
Lead Sponsor:
Shanghai University of Traditional Chinese Medicine
Collaborating Sponsors:
RenJi Hospital
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
This study evaluates the safety and efficacy of the traditional chinese medicine Zishenqing in the treatment of active systemic lupus erythematosus.
Detailed Description
This study will be a multicenter, randomized, double-blind, placebo parallel controlled clinical trial with a course of 12 weeks. 1. Multicenter: During the study period, it will be decided whether t...
Eligibility Criteria
Inclusion
- Patients who qualify for the diagnosis of systemic lupus erythematosus according to the American college of rheumatology's 1997 revised classification criteria for systemic lupus erythematosus;
- For inpatient or out-patient with good compliance, sign the informed consent before the test;
- Sledai score during screening period≤10;
- 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 treatment regimens refer to the stable use of any of the following (alone or in combination): corticosteroids, hydroxychloroquine, non-steroidal anti-inflammatory drugs, other immunosuppressants or immunomodulators (including azathioprine, mycophenolate ester, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine);
Exclusion
- Severe lupus nephritis requiring hemodialysis or high-dose glucocorticoid treatment in the last 2 months;
- Central nervous system diseases (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis) caused by SLE or non-SLE in the last 2 months;
- Patients with severe heart, liver and kidney diseases and disease history of important organs, blood and endocrine system;
- Evaluation criteria of severity:
- Alanine aminotransferase(ALT) and Aspartate aminotransferase(AST)≥3 times the upper limit of normal;
- Glomerular filtration rate(GFR)\<30ml/min;
- White Blood Cell(WBC)\<2.0×10\^9/l;
- Platelet(PLT)\<50×10\^9/l;
- Immunodeficiency, uncontrolled infection and active or recurrent peptic ulcer;
- Pregnant and lactating women;
- Anaphylaxis: allergic to traditional Chinese medicine;
- The investigator considered it inappropriate to participate in this study;
- Participate in other clinical trials during the screening period.
Key Trial Info
Start Date :
October 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT04275193
Start Date
October 22 2019
End Date
September 1 2022
Last Update
April 28 2020
Active Locations (1)
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1
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China, 200030