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

Overview

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

Full Title of Study: “The Safety and Efficacy of the Traditional Chinese Medicine Zishenqing in Subjects With Active Systemic Lupus Erythematosus”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 1, 2022

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.

Interventions

  • Drug: Zishenqing
    • Zishenqing Granule
  • Drug: Placebo
    • Granule manufactured to mimic Zishenqing(containing 10% composition)

Arms, Groups and Cohorts

  • Experimental: Zishenqing
    • The original treatment and Zishenqing 1Co by mouth,twice a day for 12 weeks
  • Placebo Comparator: Placebo
    • The original treatment and Zishenqing simulator 1Co by mouth,twice a day for 12 weeks

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Shanghai University of Traditional Chinese Medicine
  • Collaborator
    • RenJi Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: maojianchun, Professor – Shanghai University of Traditional Chinese Medicine
  • Overall Official(s)
    • Liangjing Lv, Ph.D, Study Chair, RenJi Hospital
    • Huanru Qu, Ph.D, Study Chair, Longhua Hospital
    • Zhujing Zhu, Ph.D, Study Chair, Longhua Hospital
    • Ruru Guo, Ph.D, Study Chair, RenJi Hospital
    • Zhongping Xu, Master, Study Chair, Longhua Hospital
  • Overall Contact(s)
    • Jianchun Mao, Master, +8618917763231, mjczyczx@163.com

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