Clinical trial NCT03173040: The Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid Arthritis
Official title: The Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid Arthritis: a Study Protocol for a Multicenter, Randomized, Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Niu Bang Zi Pill
Rheumatoid Arthritis
Keywords: Traditional Chinese medicine
Niu Bang Zi 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 7th People's Hospital
First posted: 2017-06-01
Enrollment: 100
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: Rheumatoid arthritis (RA) is a chronic, systemic, inflammatory autoimmune disease that results in the destruction of joints, connective tissues, muscle, tendons and fibrous tissue. Effective therapy to manage RA still does not exit at present. Jia Wei Niu Bang Zi pill (NBZP) consists of Chinese herbals which has been widely used in the treatment of RA patients in China for hundreds of years to relieve pain and prevent the affected joints pejorative. However, there is no systematic trials to prove the effect of NBZP for management of RA.

Detailed description: A multicenter, randomized, double-blind, placebo-controlled clinical trials will be conducted to determine whether the NBZP could make an effect of pain relief and joints protection. 120 patients suffering from active RA will be enrolled and treated with NBZP or placebo for 3 months. The primary outcome measures are the rate of American College of Rheumatology (ACR) 50, changes of the Disease Activity Score (DAS) 28 from the baseline to 3 months and the van der Heijde modified Sharp score would be measured from the baseline to 12 months. The second outcome measures are the change rate of ACR20, ACR70, Health Assessment Questionnaire - Disability Index, change score of Patient Assessment of Arthritis Pain, Patient Global Assessment of Arthritis, Patient Global Assessment of Arthritis and the Athens Insomnia Scale (AIS) from the baseline to 2 weeks, 1 month, 2 months, 3 months, 6 months, and 12 months' follow-up.

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 3 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: from baseline to 2 weeks
measure: change score of 36-item Short-Form Health Survey Questionnaire
timeFrame: from baseline to 1 month
measure: change score of 36-item Short-Form Health Survey Questionnaire
timeFrame: from baseline to 2 months
measure: change score of 36-item Short-Form Health Survey Questionnaire
timeFrame: from baseline to 3 months
measure: change score of 36-item Short-Form Health Survey Questionnaire
timeFrame: from baseline to 6 months
measure: change score of 36-item Short-Form Health Survey Questionnaire
timeFrame: from baseline to 12 months
measure: change score of MOS Sleep Scale
timeFrame: from baseline to 2 weeks
measure: change score of MOS Sleep Scale
timeFrame: from baseline to 1 month
measure: change score of MOS Sleep Scale
timeFrame: from baseline to 2 months
measure: change score of MOS Sleep Scale
timeFrame: from baseline to 3 months
measure: change score of MOS Sleep Scale
timeFrame: from baseline to 6 months
measure: change score of MOS 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: at 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
state: Shanghai
Study officials:
References:
citation: Wang YR, Liu L, Wang XY, Wang Q, Yao M, Cui XJ, Mao JC, Liu J, Gu XH, Chen YL, Yu X, Shi Q, Liang QQ, Wang YJ. The efficacy of the traditional Chinese medicine Jia Wei Niu Bang Zi granule combined with methotrexate in treating active rheumatoid arthritis: A multicenter, randomized, double-blinded controlled clinical trial. Medicine (Baltimore). 2019 Feb;98(6):e14424. doi: 10.1097/MD.0000000000014424.