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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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18 April 2017 |
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Main ID: |
ChiCTR-IPR-15007368 |
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Date of registration:
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2015-11-09 |
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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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Clinical Research for the Effect of Chinese and Western Medicine on Treating Rheumatoid Arthritis
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Scientific title:
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Comparative Study on the Influences of Gut Microbiota of Chinese and Western Medicine for Treatment of Rheumatoid Arthritis |
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Date of first enrolment:
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2015-12-01 |
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Target sample size:
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1:96;2:96;3:96;4:96; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=12365 |
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Study type:
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Interventional study |
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Study design:
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Randomized parallel controlled trial
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Phase:
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Pilot study
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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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Jun Wang
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Address:
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State Key Laboratory of Quality Research in Chinese Medicine, Macau University of Science and Technology, Avenida Wai Long, Taipa, Macau
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Telephone:
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+86 13510220140 |
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Email:
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yuanyuanru1@genomics.cn |
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Affiliation:
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Name:
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Hudan Pan
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Address:
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State Key Laboratory of Quality Research in Chinese Medicine, Macau University of Science and Technology, Avenida Wai Long, Taipa, Macau
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Telephone:
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+86 13226670252 |
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Email:
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panhudan1988@163.com |
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Affiliation:
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Macau university of Science and Technology |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Patient must be between 18 and 65 years of age;
2. The patient must meet 2010 American College of Rheumatology /The European League Against Rheumatism classification criteria for the diagnosis of active rheumatoid arthritis and Traditional Chinese Medicine for the diagnosis of "Wang Bi";
3. Patient has discontinued all disallowed concomitant medications foe the required time prior to the first dose of study drug;
4. Patient has signed the informed consent;
5. The patients must meet Class I-III of the Xray development in RA.
Exclusion criteria: 1. Infection, pregnancy, lactating, traumatic or other stress state;
2. Severe, progressive or uncontrolled cardiac, hepatic, renal, mental disease;
3. Severe hematologic disease including leukemia, aplastic anemia, myelodysplastic syndrome and so on;
4. Be allergic to the medicine we use in the research;
5. Use antibiotics within 1 month;
6. Patients in the Class? of RA;
7. History of other rheumatic autoimmune disease;
8. Patients with active gastrointestinal disease or pitents with peptic ulcer 4 or less weekly;
9. Patients who have previously participated in any clinical study.
Age minimum:
18
Age maximum:
65
Gender:
Male
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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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1:HuaYuTongBiFang;2:HuaYuTongBiFang+MTX;3:ZhengQingFengTongNing Pills+MTX;4:Methotrexate;
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Primary Outcome(s)
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ACR20/50/70;DAS28 ESR/CRP;TCM sympotoms rating scale;Metagenomic Linkage Group analysis;
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Secondary Outcome(s)
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HAQ-DI;CDAI;SDAI;Sharp's ??;TCM constitution score;
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Source(s) of Monetary Support
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Macao science and technology development fund
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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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