NCT04275193

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

The Safety and Efficacy of the Traditional Chinese Medicine Zishenqing in Subjects With Active Systemic Lupus Erythematosus

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 118 (estimated)
• Sponsor: Shanghai University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	Zishenqing	Zishenqing Granule
DRUG	Placebo	Granule manufactured to mimic Zishenqing(containing 10% composition)

Timeline

• Start date: 2019-10-22
• Primary completion: 2022-03-01
• Completion: 2022-09-01
• First posted: 2020-02-19
• Last updated: 2020-04-28

Locations

1 site across 1 country: China