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

Phase 2

• Conditions: Niu Bang Zi Pill; Rheumatoid Arthritis
• Interventions: Drug: NiuBangZi pill or NiuBangZi pill placebo

• Registration Number: NCT03173040
• Lead Sponsor: Cui xuejun

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.

Study Timeline

• Study First Submitted: 2017-05-30
• Study First Submitted QC: 2017-05-30
• Study First Posted: 2017-06-01
• Status Verified: 2018-07
• Study Start: 2018-07
• Last Update Submitted: 2018-07-13
• Last Update Posted: 2018-07-17
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NiuBangZi pill group	NiuBangZi pill or NiuBangZi pill placebo	Drug: 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	NiuBangZi pill or NiuBangZi pill placebo	Drug: 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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
rate of ACR20	at 12 months
Rate of ACR (American College of Rheumatology) 50	at 12 months
change score of Health Assessment Questionnaire - Disability Index	from baseline to 12 months
change score of Patient Assessment of Arthritis Pain	from baseline to 12 months
change score of Patient Global Assessment of Arthritis	from baseline to 12 months
change score of 36-item Short-Form Health Survey Questionnaire	from baseline to 12 months
changes of The Disease Activity Score (DAS) 28	from baseline to 12 months
change score of MOS Sleep Scale	from baseline to 12 months
rate of ACR70	at 12 months

Trial Locations

Locations (1)

Longhua Hospital; 🇨🇳 Shanghai, Shanghai, China