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

NCT ID: NCT04275193

Last Updated: 2020-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-22
• Study Completion Date: 2022-09-01

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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Zishenqing

The original treatment and Zishenqing 1Co by mouth,twice a day for 12 weeks

Group Type: EXPERIMENTAL

Zishenqing

Intervention Type: DRUG

Zishenqing Granule

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Granule manufactured to mimic Zishenqing(containing 10% composition)

Interventions

Zishenqing

Zishenqing Granule

Intervention Type: DRUG

Placebo

Granule manufactured to mimic Zishenqing(containing 10% composition)

Intervention Type: DRUG

Other Intervention Names

Zishenqingqi; Placebo(for Zishenqing)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: collaborator

Shanghai University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

maojianchun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liangjing Lv, Ph.D

Role: STUDY_CHAIR

RenJi Hospital

Huanru Qu, Ph.D

Role: STUDY_CHAIR

Longhua Hospital

Zhujing Zhu, Ph.D

Role: STUDY_CHAIR

Longhua Hospital

Ruru Guo, Ph.D

Role: STUDY_CHAIR

RenJi Hospital

Zhongping Xu, Master

Role: STUDY_CHAIR

Longhua Hospital

Locations

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jianchun Mao, Master

Role: CONTACT

mjczyczx@163.com

+8618917763231

Zhujing Zhu, Ph.D

Role: CONTACT

zzj01@hotmail.com

+8613816914874

Facility Contacts

Jianchun Mao, master

Role: primary

mjcct2018@163.com

86-18917763231

Other Identifiers

Zishenqing

Identifier Type: -

Identifier Source: org_study_id