Systemic Lupus Erythematosus Clinical Trial
Official title:
The Safety and Efficacy of the Traditional Chinese Medicine Zishenqing in Subjects With Active Systemic Lupus Erythematosus
This study evaluates the safety and efficacy of the traditional chinese medicine Zishenqing in the treatment of active systemic lupus erythematosus.
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.
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