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

Systemic Lupus Erythematosus Clinical Trial

Official title:

The Safety and Efficacy of the Traditional Chinese Medicine Zishenqing in Subjects With Active Systemic Lupus Erythematosus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04275193
• Other study ID #: Zishenqing
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 22, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: April 2020
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Jianchun Mao, Master
• Phone: +8618917763231
• Email: mjczyczx[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: September 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

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

Locations

Country	Name	City	State
China	Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine	RenJi Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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