Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
428 participants
INTERVENTIONAL
2015-09-30
2017-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Kunxian capsule group
Intervention:
Drug: Kunxian 2 capsules BID taken by mouth for 24 weeks. Kunxian capsule is composed of 4 ingredients: Tripterygium wilfordii Hook F 300mg, extracts from Gouqizi,Tusizi and yinyanghuo.
Kunxian Capsule
Patients in the Kunxian Capsule group will take Kunxian Capsule 0.6gm orally twice daily for 24weeks
Methotrexate group
Intervention:
Drug: Methotrexate tablet 10mg taken by mouth every week for 24 weeks.
Methotrexate
the Methotrexate group will take Methotrexate 10mg orally every week for 24 weeks
Interventions
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Kunxian Capsule
Patients in the Kunxian Capsule group will take Kunxian Capsule 0.6gm orally twice daily for 24weeks
Methotrexate
the Methotrexate group will take Methotrexate 10mg orally every week for 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Fulfill the 1987 or 2010 ACR classification criteria for RA；
3. Male or female patients, age ranged from 40-70;
4. Male or female who do not plan to have more child,or per-menopausal or menopausal women；
5. Patients with mild or moderate disease activity, ie, whose DAS28 ranged from 3.2-5.1（ie, ESR\>28mm/h，or patients who have 1-5 swollen joints as well as 1-5 tender joints）；
6. Without severe systemic disorders,such as severe pericardial effusion,pulmonary interstitial fibrosis,renal tubual acidosis,atrophic gastritis,autoimmune liver disease etc.
7. Not included in any drug trial 1 month before enrollment
Exclusion Criteria
2. Patients with active liver diseases or elevated liver enzymes eg, the ALT and/or AST is higher than 1.5 of the upper limit of normal range;
3. Patients with renal function abnormality,eg,serum creatinin higher than the upper limit of normal range；
4. White blood cell count less than 3.0×109/L，or with anemia(hemoglobin level lower than 80g/L），or platelet count less than 80×109/L，or with other hematological diseases;
5. Patients with chronic gastrointestinal diseases；
6. Patients with un-controlled hypertension,metabolic diseases such as diabetes;
7. History of malignant tumor or has malignant tumor at present;
8. With acute and/or chronic contagious diseases；
9. Severe arrhythmia on ECG test;
10. History of adverse reaction with Kunxian capsule,or Tripterygium wilfordii Hook F.,methotrexate or medications contain kunminshanhaitang ingredient；
11. History of psychiatric diseases or alcoholism or drug abuse；
12. Having been diagnosed to have systemic rheumatic diseases;
13. Ever taken immunosuppressive agents or biological agents or Tripterygium wilfordii Hook F or medications contain kunminshanhaitang ingredient in recent 3 months；
14. Had ever taken methotrexate or Kunxian capsule for more than 12 weeks but could not control the arthritis under remission；
40 Years
70 Years
ALL
No
Sponsors
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CHENLIJI Pharmaceutical Company,Guangzhou Pharmaceutical Group
UNKNOWN
CHINESE RHEUMATISM DATA CENTER
UNKNOWN
Chinese SLE Treatment And Research Group
OTHER
Responsible Party
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Xinping Tian
MD
Principal Investigators
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XIAOFENG ZENG, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
XINPING TIAN, MD
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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the Affiliated Hospital to Bangbu Medical University
Bengbu, Anhui, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
AnHui provincial hospital
Hefei, Anhui, China
Nanfang Hospital
Guangzhou, Guangdong, China
The Third Affiliated Hospital to SUN YAT-SEN University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Harbin Medcial University
Haerbin, Heilongjiang, China
The first affiliated hospital of Zhengzhou University
Zhengzhou, Henan, China
Minda Hospital of Hubei Province
Enshi, Hubei, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Xijing Hospital
Xian, Shanxi, China
the Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Guang'anmen Hospital,China Academy of Chinese Medical Sciences
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
Guang Hua hospital
Shanghai, , China
Zhongshan Hospital Fudan University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Chenliji001
Identifier Type: -
Identifier Source: org_study_id
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