The Safety and Efficacy of Zishenqing in Subjects With Active Systemic Lupus Erythematosus
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|ClinicalTrials.gov Identifier: NCT04275193|
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : April 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: Zishenqing Drug: Placebo||Phase 2 Phase 3|
This study will be a multicenter, randomized, double-blind, placebo parallel controlled clinical trial with a course of 12 weeks.
- 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.
- 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.
- Control drug: Placebo will be used as control in this trial.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||118 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Safety and Efficacy of the Traditional Chinese Medicine Zishenqing in Subjects With Active Systemic Lupus Erythematosus|
|Actual Study Start Date :||October 22, 2019|
|Estimated Primary Completion Date :||March 1, 2022|
|Estimated Study Completion Date :||September 1, 2022|
The original treatment and Zishenqing 1Co by mouth,twice a day for 12 weeks
Other Name: Zishenqingqi
Placebo Comparator: Placebo
The original treatment and Zishenqing simulator 1Co by mouth,twice a day for 12 weeks
Granule manufactured to mimic Zishenqing(containing 10% composition)
Other Name: Placebo(for Zishenqing)
- Lupus Quality of Life (LupusQoL) [ Time Frame: 12weeks ]Self reported the quality of life in patients with systemic lupus erythematosus.LupusQoL is made up of five parts((physical health, pain, planning, emotional health, and fatigue) and has a total of 34 questions.Each question is scored0-4,yielding a total between 0 and 136.
- The 36-item shot form health survey(SF-36) [ Time Frame: 12weeks ]As a concise health questionnaire, SF-36 comprehensively summarizes the quality of life of the subjects from eight aspects: physiological function, physiological function, physical pain, general health status, energy, social function, emotional function and mental health.
- Systemic lupus erythematosus disease activity index(SLEDAI) [ Time Frame: 12weeks ]SLEDAI scores are used to determine the activity of SLE.SLEDAI consists of 24 clinical and laboratory projects with different weights（0:no activity;1-5:mild activity;6-10:moderate activity;11-19:severe activity;≥20:extremely severe activity).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04275193
|Contact: Jianchun Mao, Masteremail@example.com|
|Contact: Zhujing Zhu, Ph.Dfirstname.lastname@example.org|
|Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine||Recruiting|
|Shanghai, Shanghai, China, 200030|
|Contact: Jianchun Mao, master 86-18917763231 email@example.com|
|Study Chair:||Liangjing Lv, Ph.D||RenJi Hospital|
|Study Chair:||Huanru Qu, Ph.D||Longhua Hospital|
|Study Chair:||Zhujing Zhu, Ph.D||Longhua Hospital|
|Study Chair:||Ruru Guo, Ph.D||RenJi Hospital|
|Study Chair:||Zhongping Xu, Master||Longhua Hospital|