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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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5 May 2019 |
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Main ID: |
ChiCTR1900022934 |
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Date of registration:
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2019-05-04 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin
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Scientific title:
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Study for the metabolic mechanism of Langchuangjing granule in the treatment of systemic lupus erythematosusin |
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Date of first enrolment:
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2019-06-20 |
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Target sample size:
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Experimental group:20;control group:20;healthy control group:20; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=35961 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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1
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Countries of recruitment
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China
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Contacts
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Name:
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Guo Feng
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Address:
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155 Hanzhoung Road, Nanjing, Jiangsu, China
210026
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Telephone:
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+86 13914704686 |
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Email:
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178837922@qq.com |
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Affiliation:
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Jiangsu Province Hospital of TCM |
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Name:
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Guo Feng
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Address:
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155 Hanzhoung Road, Nanjing, Jiangsu, China
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Telephone:
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+86 13914704686 |
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Email:
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178837922@qq.com |
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Affiliation:
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Jiangsu Province Hospital of TCM |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Meet the diagnostic criteria of SLE and the syndrome differentiation standard of TCM kidney deficiency and phlegm syndrome;
2. Aged 18 and 65 years old male and female;
3. Patients who have used or are using hormone therapy;
4. SLEDAI=5;
5. Informed consent, volunteering to be tested. The process of obtaining informed consent should be in accordance with GCP regulations.
Exclusion criteria: 1. Patients have combined with serious diseases such as infections and tumors;
2. With other rheumatisms such as rheumatoid arthritis, scleroderma, polymyositis, and Sjogren's syndrome;
3. The condition is critical and it is difficult to make a definitive assessment of the effectiveness of this trial;
4. Pregnant, lactating women;
5. Persons with intellectual or behavioral disorders unable to give informed consent;
6. Suspected or indeed have a history of alcohol and drug abuse;
7. According to the judgment of the investigator, other lesions that have the possibility of reducing the enrollment or complicating the enrollment, such as frequent changes in the working environment, are likely to cause loss of follow-up;
8. Allergies, such as those who have a history of allergies to two or more drugs or foods; or those who are known to be allergic to the ingredients.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Experimental group:Langchuangjing granule + Prednisone acetate tablets, Hydroxychloroquine;control group:Prednisone acetate tablets?Hydroxychloroquine;healthy control group:nothing;
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Primary Outcome(s)
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Metabolomics;SLEDAI;blood pressure;Proteomics;
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Source(s) of Monetary Support
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Nanjing University of Chinese Medicine Affiliated Hospital
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Ethics review
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Status: Approved
Approval date: 19/01/2019
Contact:
Wu Jing
+86 025-86560515
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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