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

Shanghai University of Traditional Chinese Medicine

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Zishenqing; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04275193

Zishenqing

Details and patient eligibility

About

This study evaluates the safety and efficacy of the traditional chinese medicine Zishenqing in the treatment of active systemic lupus erythematosus.

Full 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.

Enrollment: 118 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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118 participants in 2 patient groups, including a placebo group

Zishenqing

Experimental group

Description:

The original treatment and Zishenqing 1Co by mouth,twice a day for 12 weeks

Treatment:

Drug: Zishenqing

Placebo

Placebo Comparator group

Description:

The original treatment and Zishenqing simulator 1Co by mouth,twice a day for 12 weeks

Treatment:

Drug: Placebo