The Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid Arthritis

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cui xuejun
• Collaborators: Longhua Hospital; Shanghai Seventh People's Hospital; Shanghai Yueyang Integrated Medicine Hospital
• Treatments: Methotrexate

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