Clinical trial NCT04275193: The Safety and Efficacy of Zishenqing in Subjects With Active Systemic Lupus Erythematosus
Official title: The Safety and Efficacy of the Traditional Chinese Medicine Zishenqing in Subjects With Active Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Systemic Lupus Erythematosus
Keywords: Safety
Efficacy
Systemic Lupus Erythematosus
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: RenJi Hospital
First posted: 2020-02-19
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 to increase the improvement progress of the research unit according to whether it will be difficult to join the group and the overall progress, so as to complete the clinical study on time in accordance with the research plan.
2. Random scheme: In this study, a dynamic random variance minimization random scheme will be adopted. Considering the two influencing factors of SLEDAI score and complement level, the DAS for Interactive Web Response System(IWRS) will be used to calculate and distribute random numbers and dispensing drugs.
3. Control drug: Placebo will be used as control in this trial.
4. Blind method: The Zishenqing simulator will be prepared by double-blind design, the dosage form, appearance, size, color and smell will be consistent with the experimental drug, and the test process will be in a double-blind state.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. For inpatient or out-patient with good compliance, sign the informed consent before the 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 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 Criteria:

1. Severe lupus nephritis requiring hemodialysis or high-dose glucocorticoid treatment in the last 2 months;
2. 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;
3. Patients with severe heart, liver and kidney diseases and disease history of important organs, blood and endocrine system;

   Evaluation criteria of severity:
   1. Alanine aminotransferase(ALT) and Aspartate aminotransferase(AST)≥3 times the upper limit of normal;
   2. Glomerular filtration rate(GFR)\<30ml/min;
   3. White Blood Cell(WBC)\<2.0×10\^9/l;
   4. Platelet(PLT)\<50×10\^9/l;
4. Immunodeficiency, uncontrolled infection and active or recurrent peptic ulcer;
5. Pregnant and lactating women;
6. Anaphylaxis: allergic to traditional Chinese medicine;
7. The investigator considered it inappropriate to participate in this study;
8. Participate in other clinical trials during the screening period.

Primary outcomes:
measure: Lupus Quality of Life (LupusQoL)
timeFrame: 12weeks
Secondary outcomes:
measure: The 36-item shot form health survey(SF-36)
timeFrame: 12weeks
measure: Systemic lupus erythematosus disease activity index(SLEDAI)
timeFrame: 12weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Liangjing Lv, Ph.D
role: STUDY_CHAIR
affiliation: Longhua Hospital
name: Huanru Qu, Ph.D
role: STUDY_CHAIR
affiliation: Longhua Hospital
name: Zhujing Zhu, Ph.D
role: STUDY_CHAIR
affiliation: RenJi Hospital
name: Ruru Guo, Ph.D
role: STUDY_CHAIR
affiliation: Longhua Hospital
name: Zhongping Xu, Master
role: STUDY_CHAIR
References: