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

Phase 2

• Conditions: Systemic Lupus Erythematosus
• Interventions: Drug: Zishenqing; Drug: Placebo

• Registration Number: NCT04275193
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

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.

Study Timeline

• Study Start: 2019-10-22
• Study First Submitted: 2020-02-12
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-19
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-26
• Last Update Posted: 2020-04-28
• Primary Completion: 2022-03-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 118

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Lupus Quality of Life (LupusQoL)	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.

Secondary Outcome Measures

Name	Time	Method
The 36-item shot form health survey(SF-36)	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)	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).

Trial Locations

Locations (1)

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine; 🇨🇳 Shanghai, Shanghai, China