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

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

Study Overview

• Status: Unknown
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: Zishenqing; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 118
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Jianchun Mao, Master; Phone Number: +8618917763231; Email: mjczyczx@163.com
• Study Contact Backup: Name: Zhujing Zhu, Ph.D; Phone Number: +8613816914874; Email: zzj01@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Recruiting
      • Longhua Hospital affiliated to Shanghai University of Traditional Chinese Medicine
      • Contact: Jianchun Mao, master; Phone Number: 86-18917763231; Email: mjcct2018@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Zishenqing; The original treatment and Zishenqing 1Co by mouth,twice a day for 12 weeks	Drug: Zishenqing; Zishenqing Granule; Other Names: 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 Names: Placebo(for Zishenqing)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lupus Quality of Life (LupusQoL)	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.	12weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The 36-item shot form health survey(SF-36)	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.	12weeks
Systemic lupus erythematosus disease activity index(SLEDAI)	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).	12weeks

Collaborators and Investigators

• Sponsor: Shanghai University of Traditional Chinese Medicine
• Collaborators: RenJi Hospital
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2019
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: February 12, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 19, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 26, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Systemic Lupus Erythematosus
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: Zishenqing

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No