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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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ITMCTR |
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Last refreshed on:
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20 February 2023 |
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Main ID: |
ITMCTR2100005063 |
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Date of registration:
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2021-07-16 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A prospective non-randomized controlled study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosus
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Scientific title:
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A prospective cohort study of integrated traditional Chinese and western medicine for moderately active systemic lupus erythematosus |
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Date of first enrolment:
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2021-07-15 |
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Target sample size:
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Experimental group:264;Control Group:264; |
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Recruitment status: |
Pending |
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URL:
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http://itmctr.ccebtcm.org.cn/en-US/Home/ProjectView?pid=3ab11f43-5022-48ad-be1a-d9586dc67ca0 |
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Study type:
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Interventional study |
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Study design:
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Non randomized control
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Phase:
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N/A
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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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Xie Zhijun
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Address:
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548 Binwen Road, Binjiang District, Hangzhou, Zhejiang, China
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Telephone:
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+86 571 86613587 |
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Email:
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xzj575@163.com |
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Affiliation:
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Zhejiang Chinese Medical University |
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Name:
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Wen Chengping
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Address:
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548 Binwen Road, Binjiang District, Hangzhou, Zhejiang, China
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Telephone:
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+86 13906514781 |
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Email:
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wengcp@163.com |
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Affiliation:
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Zhejiang Chinese Medical University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Comply with the 2019 EULAR/ACR SLE classification standards;
2. Those who meet the TCM syndrome differentiation of heat toxin, blood stasis and kidney deficiency;
3.7 <= SLEDAI-2000 <=12 points and the current glucocorticoid dosage (calculated by prednisone) <= 1 mg/kg.d;
4. Those between the ages of 18 and 60;
5. Those who voluntarily participate in this trial and agree to sign the informed consent for entering the clinical research.
Exclusion criteria: 1. Neuropsychiatric lupus patients or lupus crisis patients;
2. Patients with severe diseases of target organs of various systems, mental illness, tumors and other diseases;
3. Patients who cannot tolerate the drug treatment of this study;
4. Pregnant and lactating women;
5. Patients who are participating in other clinical trials;
6. The researchers believe that other reasons are not suitable for clinical trials.
Age minimum:
18
Age maximum:
65
Gender:
Female
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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:Western medicine + Jiedu Quyu Zishen Fang's modified treatment based on syndrome differentiation;Control Group:Western Medicine (glucocorticoid, hydroxychloroquine, methotrexate, azathioprine or cyclophosphamide);
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Primary Outcome(s)
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Systemic lupus erythematosus disease activity score;
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Secondary Outcome(s)
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LupusQoL quality of life;Number of severe infections;TCM syndrome score;Changes of biomarker indicators before and after treatment;
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Secondary ID(s)
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ChiCTR2100048796
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ChiMCTR2100005063
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Source(s) of Monetary Support
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Self-funded
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Ethics review
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Status: Approved
Approval date: 12/07/2021
Contact:
Wu Chengliang
+86 571 87070579
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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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