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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04275193
Recruitment Status : Recruiting
First Posted : February 19, 2020
Last Update Posted : April 28, 2020
Sponsor:
Collaborator:
RenJi Hospital
Information provided by (Responsible Party):
maojianchun, 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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: Zishenqing Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Zishenqing
The original treatment and Zishenqing 1Co by mouth,twice a day for 12 weeks
Drug: Zishenqing
Zishenqing Granule
Other Name: Zishenqingqi

Placebo Comparator: Placebo
The original treatment and Zishenqing simulator 1Co by mouth,twice a day for 12 weeks
Drug: Placebo
Granule manufactured to mimic Zishenqing(containing 10% composition)
Other Name: Placebo(for Zishenqing)




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Jianchun Mao, Master +8618917763231 mjczyczx@163.com
Contact: Zhujing Zhu, Ph.D +8613816914874 zzj01@hotmail.com

Locations
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China, Shanghai
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine Recruiting
Shanghai, Shanghai, China, 200030
Contact: Jianchun Mao, master    86-18917763231    mjcct2018@163.com   
Sponsors and Collaborators
Shanghai University of Traditional Chinese Medicine
RenJi Hospital
Investigators
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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
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Responsible Party: maojianchun, Professor, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT04275193    
Other Study ID Numbers: Zishenqing
First Posted: February 19, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by maojianchun, Shanghai University of Traditional Chinese Medicine:
Safety
Efficacy
Systemic Lupus Erythematosus
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases