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| Name | Class |
|---|---|
| RenJi Hospital | OTHER |
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This study evaluates the safety and efficacy of the traditional chinese medicine Zishenqing in the treatment of active systemic lupus erythematosus.
This study will be a multicenter, randomized, double-blind, placebo parallel controlled clinical trial with a course of 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zishenqing | Experimental | The original treatment and Zishenqing 1Co by mouth,twice a day for 12 weeks |
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| Placebo | Placebo Comparator | The original treatment and Zishenqing simulator 1Co by mouth,twice a day for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zishenqing | Drug | Zishenqing Granule |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianchun Mao, Master | Contact | +8618917763231 | mjczyczx@163.com | |
| Zhujing Zhu, Ph.D | Contact | +8613816914874 | zzj01@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Liangjing Lv, Ph.D | RenJi Hospital | Study Chair |
| Huanru Qu, Ph.D | Longhua Hospital | Study Chair |
| Zhujing Zhu, Ph.D |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine | Recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| Placebo | Drug | Granule manufactured to mimic Zishenqing(containing 10% composition) |
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| 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 |
| Longhua Hospital |
| Study Chair |
| Ruru Guo, Ph.D | RenJi Hospital | Study Chair |
| Zhongping Xu, Master | Longhua Hospital | Study Chair |