Clinical trial NCT02885597: Juanbi Pill for Rheumatoid Arthritis
Official title: Juanbi Pill Combined With Methotrexate for Rheumatoid Arthritis: Multi-center Random Controlled Clinical Trials
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Juanbi Pill
Rheumatoid Arthritis
Keywords: Juanbi Pill
Methotrexate
Active
Rheumatoid Arthritis
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Yueyang Integrated Medicine Hospital
name: Longhua Hospital
name: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
First posted: 2016-08-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Juanbi Pill combined with methotrexate are effective in the treatment of active Rheumatoid Arthritis (RA).

Detailed description: Rheumatoid arthritis patients are suffering from painful and swelling of joints as well as joint destruction and functional disability with the duration of disease activity. Patients and physician try to find a way to alleviate the swell and tenderness of joints to avoid irreversible joints impairment, for evidence indicating that early aggressive treatment results in greater improvement than therapy initiated later in the disease course.

As a complementary and alternative medicine (CAM), herbal medicines have the potential to achieve a clinical remission, or push the disease back to low disease activity. In traditional Chinese medicine (TCM), rheumatoid arthritis is a Bi syndrome and Juanbi decotion (notopterygium root, radix angelicae pubescentis, Gentiana macrophylla, Kadsura Pepper Stem, Mulberry Twig, Angelica sinensis, Ligusticum wallichii, frankincense, Radix Aucklandiae, shaved cinnamon barka and liquorice ) is a medicine specially for Bi syndrome and it has been used in Chinese for hundreds of years. Juanbi pill is the raw extration of Juanbi decotion for the sake of convenience of quality control and storage.

Although the long term usage of Juanbi decotion, there is no high quality evidence about the decotion on rheumatoid arthritis. Using a well-designed clinical trial, the investigators will survey the effectiveness of concurrent use of this decotion in relieving disease activity. Therefore, the present study is to examine effectiveness and safety of Juanbi Pill, a compound traditional Chinese herbal medicine on rheumatoid arthritis in a randomized, double-blind, placebo-controlled trial. Results of this study will provide evidence regarding the value of the Juanbi pill as an intervention to lower the disease activity and protect the affected joints from deformity.

Eligibility criteria: Inclusion Criteria:

* Adults with rheumatoid arthritis (score more then 5 of ACR (American College Of Rheumatology) /EULAR (European League Against Rheumatism), 2009 )
* moderate-to-severe disease activity (Disease Activity Score for 28-joint counts (DAS28) of more than 3.2
* an onset of symptoms within 12 months before enrollment, no prior exposure to more than 10mg oral glucocorticoids or biologic agents
* paid employment or unpaid but measurable work (e.g., caring for a family and home)

Exclusion Criteria:

* combined with other disease such as adjuvant arthritis, lupus arthritis, osteoarthritis and et al.
* abnormal liver and my kidney function
* pregnancy or have a plan of pregnancy,breast feeding women
* severe chronic or acute disease interfering with therapy attendance
* alcohol or substance abuse

Primary outcomes:
measure: Rate of ACR (American College Of Rheumatology) 50
timeFrame: at 3 months
measure: changes of The Disease Activity Score (DAS) 28
timeFrame: from baseline to 3 months
measure: changes of the van der Heijde modified Sharp score
timeFrame: from baseline to 12 months
Secondary outcomes:
measure: changes of The Disease Activity Score (DAS) 28
timeFrame: from baseline to 2 weeks
measure: changes of The Disease Activity Score (DAS) 28
timeFrame: from baseline to 1 month
measure: changes of The Disease Activity Score (DAS) 28
timeFrame: from baseline to 6 months
measure: changes of The Disease Activity Score (DAS) 28
timeFrame: from baseline to 12 months
measure: Rate of ACR(American College Of Rheumatology)50
timeFrame: at 2 weeks
measure: Rate of ACR(American College Of Rheumatology)50
timeFrame: at 1 month
measure: Rate of ACR(American College Of Rheumatology)50
timeFrame: at 2 months
measure: Rate of ACR(American College Of Rheumatology)50
timeFrame: at 6 months
measure: Rate of ACR(American College Of Rheumatology)50
timeFrame: at 12 months
measure: change score of Health Assessment Questionnaire - Disability Index
timeFrame: from baseline to 2 weeks
measure: change score of Health Assessment Questionnaire - Disability Index
timeFrame: from baseline to 1 month
measure: change score of Health Assessment Questionnaire - Disability Index
timeFrame: from baseline to 2 months
measure: change score of Health Assessment Questionnaire - Disability Index
timeFrame: from baseline to 3 months
measure: change score of Health Assessment Questionnaire - Disability Index
timeFrame: from baseline to 6 months
measure: change score of Health Assessment Questionnaire - Disability Index
timeFrame: from baseline to 12 months
measure: change score of Patient Assessment of Arthritis Pain
timeFrame: from baseline to 2 weeks
measure: change score of Patient Assessment of Arthritis Pain
timeFrame: from baseline to 1 month
measure: change score of Patient Assessment of Arthritis Pain
timeFrame: from baseline to 2 months
measure: change score of Patient Assessment of Arthritis Pain
timeFrame: from baseline to 3 months
measure: change score of Patient Assessment of Arthritis Pain
timeFrame: from baseline to 6 months
measure: change score of Patient Assessment of Arthritis Pain
timeFrame: from baseline to 12 months
measure: change score of Patient Global Assessment of Arthritis
timeFrame: from baseline to 2 weeks
measure: change score of Patient Global Assessment of Arthritis
timeFrame: from baseline to 1 month
measure: change score of Patient Global Assessment of Arthritis
timeFrame: from baseline to 2 months
measure: change score of Patient Global Assessment of Arthritis
timeFrame: from baseline to 3 months
measure: change score of Patient Global Assessment of Arthritis
timeFrame: from baseline to 6 months
measure: change score of Patient Global Assessment of Arthritis
timeFrame: from baseline to 12 months
measure: change score of 36-item Short-Form Health Survey Questionnaire
timeFrame: form baseline to 2 weeks
measure: change score of 36-item Short-Form Health Survey Questionnaire
timeFrame: form baseline to 1 month
measure: change score of 36-item Short-Form Health Survey Questionnaire
timeFrame: form baseline to 2 months
measure: change score of 36-item Short-Form Health Survey Questionnaire
timeFrame: form baseline to 3 months
measure: change score of 36-item Short-Form Health Survey Questionnaire
timeFrame: form baseline to 6 months
measure: change score of 36-item Short-Form Health Survey Questionnaire
timeFrame: form baseline to 12 months
measure: change score of AIS Sleep Scale
timeFrame: from baseline to 2 weeks
measure: change score of AIS Sleep Scale
timeFrame: from baseline to 1 month
measure: change score of AIS Sleep Scale
timeFrame: from baseline to 2 months
measure: change score of AIS Sleep Scale
timeFrame: from baseline to 3 months
measure: change score of AIS Sleep Scale
timeFrame: from baseline to 6 months
measure: change score of AIS Sleep Scale
timeFrame: from baseline to 12 months
measure: rate of ACR20
timeFrame: at 2 weeks
measure: rate of ACR20
timeFrame: at 1 month
measure: rate of ACR20
timeFrame: at 2 months
measure: rate of ACR20
timeFrame: at 3 months
measure: rate of ACR20
timeFrame: at 6 months
measure: rate of ACR20
timeFrame: 12 months
measure: rate of ACR70
timeFrame: at 2 weeks
measure: rate of ACR70
timeFrame: at 1 month
measure: rate of ACR70
timeFrame: at 2 months
measure: rate of ACR70
timeFrame: at 3 months
measure: rate of ACR70
timeFrame: at 6 months
measure: rate of ACR70
timeFrame: at 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital, Shanghai University of TCM
state: Shanghai
Study officials:
References:
citation: Wang Q, Wang YR, Jia QY, Liu L, Xu CQ, Wang XY, Yao M, Cui XJ, Shi Q, Wang YJ, Liang QQ. The efficacy of the traditional Chinese medicine Juanbi pill combined with methotrexate in active rheumatoid arthritis: study protocol for a randomized controlled trial. Trials. 2018 Mar 20;19(1):188. doi: 10.1186/s13063-018-2555-1.