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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: |
ITMCTR2000003729 |
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Date of registration:
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2020-08-26 |
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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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The Effect of Bushen Jiedu Tongluo Decoction in the treatment of active rheumatoid arthritis: a randomized, double-blind, controlled clinical study
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Scientific title:
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The Effect of Bushen Jiedu Tongluo Decoction in the treatment of active rheumatoid arthritis: a randomized, double-blind, controlled clinical study |
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Date of first enrolment:
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2020-10-01 |
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Target sample size:
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experimental group:53;control group:53; |
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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=9d3be20e-dfed-4384-a59c-c5521d7c37e7 |
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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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0
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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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He Yikun
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Address:
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Rheumatologist's Office, 14th Floor, Inpatient Department, Shuguang Hospital, 185 Pu'an Road, Huangpu District, Shanghai
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Telephone:
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+86 18917565332 |
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Email:
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hhyykk@126.com |
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Affiliation:
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Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine |
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Name:
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He Yikun
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Address:
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Rheumatologist's Office, 14th Floor, Inpatient Department, Shuguang Hospital, 185 Pu'an Road, Huangpu District, Shanghai
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Telephone:
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+86 18917565332 |
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Email:
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hhyykk@126.com |
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Affiliation:
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Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. According to the diagnostic criteria of RA, it is in accordance with the diagnostic criteria of RA in active stage, in accordance with the diagnostic criteria of traditional Chinese medicine;
2. Patients aged 18-80 years old;
3. The dosage of corticosteroids was stable for at least 30 days before entering the trial, and remained unchanged in the following treatment. Patients receiving other DMARDs had to discontinue other DMARDs for more than 30 days;
4. At least 30 days before entering the trial, no NSAIDs were taken;
5. Sign the informed consent to enter the clinical study.
Exclusion criteria: 1. Patients with pulmonary interstitial disease and elevated liver enzymes (ALT > 2 times normal value);
2. Pregnant and lactating women or patients who are ready to give birth in the near future;
3. Allergy to the test drug or allergic constitution;
4. Severe primary diseases, such as heart, liver, kidney, brain, endocrine system and hematopoietic system, were complicated;
5. Overlap other rheumatic diseases, such as systemic lupus erythematosus, Sjogren's syndrome, myositis, etc.
Age minimum:
18
Age maximum:
80
Gender:
Both
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Health Condition(s) or Problem(s) studied
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rheumatoid arthritis
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Intervention(s)
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experimental group:MTX 15mg qw po+Bushen Jiedu Tongluo Decoction Granule One dose a day, two times a day;control group:MTX 15mg qw po+placebo Granule One dose a day, two times a day;
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Primary Outcome(s)
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DAS28;Erythrocyte sedimentation rate;VAS test;Musculoskeletal ultrasound (synovitis);Musculoskeletal ultrasound (synovitis of tendon sheath);Musculoskeletal ultrasound (bone erosion);C-reactive protein;
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Secondary Outcome(s)
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VEGF;CX3CL1;MMP-9;TCM syndrome curative effect score;HAQ Disability Index, HAQ-DI;TNF-a;Joint tenderness count;Joint swelling count;iNOS;
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Secondary ID(s)
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ChiMCTR2000003729
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ChiCTR2000037008
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Source(s) of Monetary Support
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Shanghai Shenkang Hospital Development Center
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Ethics review
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Status: Approved
Approval date: 24/08/2020
Contact:
Geng Xi
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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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