The Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid Arthritis
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2018
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2017
CompletedFirst Posted
Study publicly available on registry
June 1, 2017
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJuly 17, 2018
July 1, 2018
5 months
May 30, 2017
July 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Rate of ACR (American College of Rheumatology) 50
at 3 months
changes of The Disease Activity Score (DAS) 28
from baseline to 3 months
changes of the van der Heijde modified Sharp score
from baseline to 3 months
Secondary Outcomes (51)
changes of The Disease Activity Score (DAS) 28
from baseline to 2 weeks
changes of The Disease Activity Score (DAS) 28
from baseline to 1 month
changes of The Disease Activity Score (DAS) 28
from baseline to 6 months
changes of The Disease Activity Score (DAS) 28
from baseline to 12 months
Rate of ACR (American College of Rheumatology) 50
at 2 weeks
- +46 more secondary outcomes
Study Arms (2)
NiuBangZi pill group
EXPERIMENTALDrug: NiuBangZi pill (4g, twice a day, 3 months, oral) Drug: methotrexate (5mg, once a week, 3 months, oral) participants should administrate both NiuBangZi pill and methotrexate
Placeo group
PLACEBO COMPARATORDrug: NiuBangZi placebo pill (4g, twice a day, 3 months, oral) Drug: methotrexate (5mg, once a week, 3 months, oral) participants should administrate both NiuBangZi placebo pill and methotrexate
Interventions
For the treatment group (NiuBangZi pill group), patients will be instructed to dissolve NiuBangZi pill (4 g) in 200 mL hot water and take the solution orally twice a day for 3 months. While patients in the placebo group will take NiuBangZi pill placebo as the same way. Besides that, both groups will also administrate MTX (5 mg per week) in addition, and glucocorticoid (less than 5mg a day) if necessary, but any other drugs especially herbs not permit.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cui xuejunlead
- Shanghai Yueyang Integrated Medicine Hospitalcollaborator
- Longhua Hospitalcollaborator
- Shanghai 7th People's Hospitalcollaborator
Study Sites (1)
Longhua Hospital
Shanghai, Shanghai Municipality, China
Related Publications (1)
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.
PMID: 30732199DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
May 30, 2017
First Posted
June 1, 2017
Study Start
July 1, 2018
Primary Completion
December 1, 2018
Study Completion
December 1, 2018
Last Updated
July 17, 2018
Record last verified: 2018-07