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

NCT04275193 | Unknown Phase 2 DMC

• 1 other identifier: Zishenqing
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Systemic Lupus Erythematosus

Keywords

Safety; Efficacy; Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The 36-item shot form health survey(SF-36)

  12weeks

• Systemic lupus erythematosus disease activity index(SLEDAI)

  12weeks

Study Arms (2)

Zishenqing

EXPERIMENTAL

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

Drug: Zishenqing

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Zishenqing DRUG

Zishenqing Granule

Also known as: Zishenqingqi

Zishenqing

Placebo DRUG

Granule manufactured to mimic Zishenqing(containing 10% composition)

Also known as: Placebo(for Zishenqing)

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• For inpatient or out-patient with good compliance, sign the informed consent before the test;
• Sledai score during screening period≤10;
• 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);

You may not qualify if:

• Severe lupus nephritis requiring hemodialysis or high-dose glucocorticoid treatment in the last 2 months;
• 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;
• Patients with severe heart, liver and kidney diseases and disease history of important organs, blood and endocrine system;
• Evaluation criteria of severity:
• Alanine aminotransferase(ALT) and Aspartate aminotransferase(AST)≥3 times the upper limit of normal;
• Glomerular filtration rate(GFR)\<30ml/min;
• White Blood Cell(WBC)\<2.0×10\^9/l;
• Platelet(PLT)\<50×10\^9/l;
• Immunodeficiency, uncontrolled infection and active or recurrent peptic ulcer;
• Pregnant and lactating women;
• Anaphylaxis: allergic to traditional Chinese medicine;
• The investigator considered it inappropriate to participate in this study;
• Participate in other clinical trials during the screening period.

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead
• RenJi Hospital: collaborator

Study Sites (1)

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• 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 CHAIR

Central Study Contacts

Jianchun Mao, Master

CONTACT

+8618917763231; mjczyczx@163.com

Zhujing Zhu, Ph.D

CONTACT

+8613816914874; zzj01@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 19, 2020
• Study Start: October 22, 2019
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 28, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)