A Clinical Study of Xin'an Medicine in the Treatment of Bi Syndrome
NCT ID: NCT01774877
Last Updated: 2014-12-19
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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COMPLETED
NA
304 participants
INTERVENTIONAL
2013-07-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Xinfeng capsule & placebo
1. Xinfeng capsule:Three each time, 3 times a day, Oral,for 3 months
2. placebo(for leflunomide): 10 mg each time, 1 time a day, Oral,for3 months
Xinfeng capsule
Xinfeng capsule:Three each time, 3 times a day, Oral,for 3 months; placebo(for leflunomide):10mg each time, 1 time a day, Oral,for 3 months; Participants will continue on the stable dose of glucocorticoids and NSAIDs that they were receiving prior to study entry
leflunomide & placebo
1. leflunomide :10mg each time, one time a day, by mouth,for 3 months
2. placebo(for xinfeng capsule):Three each time, 3 times a day, Oral,for3 months
leflunomide
leflunomide :10mg each time, one time a day, Oral,for 3 months; placebo(for xinfeng capsule):Three each time, 3 times a day, Oral,for 3 months; Participants will continue on the stable dose of glucocorticoids and NSAIDs that they were receiving prior to study entry
Interventions
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Xinfeng capsule
Xinfeng capsule:Three each time, 3 times a day, Oral,for 3 months; placebo(for leflunomide):10mg each time, 1 time a day, Oral,for 3 months; Participants will continue on the stable dose of glucocorticoids and NSAIDs that they were receiving prior to study entry
leflunomide
leflunomide :10mg each time, one time a day, Oral,for 3 months; placebo(for xinfeng capsule):Three each time, 3 times a day, Oral,for 3 months; Participants will continue on the stable dose of glucocorticoids and NSAIDs that they were receiving prior to study entry
Eligibility Criteria
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Inclusion Criteria
* According with the Zheng diagnosis of Traditional Chinese Medicine.
* age from 18 to 65 years.
* For patients currently receiving non-steroidal anti-inflammatory drugs (NSAIDs): Treatment at a stable dose during last 4 weeks prior to screening，or Patients do not take NSAIDs at least 1 weeks prior to screening.
* Patients not taking DMARDs at least 4 weeks prior to screening.
* Patients taking corticosteroids (≤15mg prednisone or Equivalent) ≥4 weeks before entering the trial.
* Patients agree to participate in this study and sign the informed consent form.
Exclusion Criteria
* Patients have high disease activity (DAS28-3 scores\> 5.1).
* Patients have diagnosed any other chronic inflammatory disease or connective tissue disease like sicca syndrome（SS）, systemic lupus erythematosus (SLE)etc;
* Patients with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system ;
* Patients who are pregnant or nursing mothers or Psychiatric patients.
* Patients with active gastroduodenal ulcer or gastritis which caused by long-term use of NSAIDs;
* The patient who has known hypersensitivity to trial medicine .
* Patients have participated in other clinical trials within 4 weeks of screening.
18 Years
65 Years
ALL
No
Sponsors
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Ministry of Science and Technology of the People´s Republic of China
OTHER_GOV
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
OTHER
Responsible Party
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Liu Jian
professor，Chief Physician
Principal Investigators
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liu jiu, doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Locations
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The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China
The first affiliated hospital of anhui medical university
Hefei, Anhui, China
Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, China
Countries
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References
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Liu J, Wang Y, Huang C, Xu J, Li Z, Xu L, He L, Sun Y, Wang Y, Xu S, Zhao P, Mao T, Tan B, Zhu F, Zhang P, Fang L. Efficacy and safety of Xinfeng capsule in patients with rheumatoid arthritis: a multi-center parallel-group double-blind randomized controlled trial. J Tradit Chin Med. 2015 Oct;35(5):487-98. doi: 10.1016/s0254-6272(15)30130-8.
Liu J, Huang CB, Wang Y, Xu GQ, Cheng YY, Feng YX, Liu L, Qi YJ. Chinese herbal medicine Xinfeng Capsule in treatment of rheumatoid arthritis: study protocol of a multicenter randomized controlled trial. J Integr Med. 2013 Nov;11(6):428-34. doi: 10.3736/jintegrmed2013059.
Other Identifiers
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2012BAI26B02
Identifier Type: -
Identifier Source: org_study_id