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

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

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.

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis; Niu Bang Zi Pill
• Intervention / Treatment: Drug: NiuBangZi pill or NiuBangZi pill placebo

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Yongjun Wang, Doctor; Phone Number: 86-18917763018; Email: yjwang8888@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Longhua Hospital
      • Contact: Qianqian Liang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NiuBangZi pill group; 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	Drug: NiuBangZi pill or NiuBangZi pill placebo; 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.
Placebo Comparator: Placeo group; 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	Drug: NiuBangZi pill or NiuBangZi pill placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
changes of The Disease Activity Score (DAS) 28	from baseline to 3 months
Rate of ACR (American College of Rheumatology) 50	at 3 months
changes of the van der Heijde modified Sharp score	from baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
change score of Patient Assessment of Arthritis Pain	from baseline to 2 weeks
change score of 36-item Short-Form Health Survey Questionnaire	from baseline to 2 weeks
rate of ACR20	at 2 weeks
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
change score of Health Assessment Questionnaire - Disability Index	from baseline to 2 weeks
change score of Health Assessment Questionnaire - Disability Index	from baseline to 1 month
change score of Health Assessment Questionnaire - Disability Index	from baseline to 2 months
change score of Health Assessment Questionnaire - Disability Index	from baseline to 3 months
change score of Health Assessment Questionnaire - Disability Index	from baseline to 6 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 1 month
change score of Patient Assessment of Arthritis Pain	from baseline to 2 months
change score of Patient Assessment of Arthritis Pain	from baseline to 3 months
change score of Patient Assessment of Arthritis Pain	from baseline to 6 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 2 weeks
change score of Patient Global Assessment of Arthritis	from baseline to 1 month
change score of Patient Global Assessment of Arthritis	from baseline to 2 months
change score of Patient Global Assessment of Arthritis	from baseline to 3 months
change score of Patient Global Assessment of Arthritis	from baseline to 6 months
change score of Patient Global Assessment of Arthritis	from baseline to 12 months
rate of ACR20	at 1 month
rate of ACR20	at 2 months
rate of ACR20	at 3 months
rate of ACR20	at 6 months
rate of ACR70	at 2 weeks
rate of ACR70	at 1 month
rate of ACR70	at 2 months
rate of ACR70	at 3 months
rate of ACR70	at 6 months
rate of ACR70	at 12 months
Rate of ACR (American College of Rheumatology) 50	at 2 weeks
Rate of ACR (American College of Rheumatology) 50	at 1 month
Rate of ACR (American College of Rheumatology) 50	at 2 months
Rate of ACR (American College of Rheumatology) 50	at 6 months
Rate of ACR (American College of Rheumatology) 50	at 12 months
change score of 36-item Short-Form Health Survey Questionnaire	from baseline to 1 month
change score of 36-item Short-Form Health Survey Questionnaire	from baseline to 2 months
change score of 36-item Short-Form Health Survey Questionnaire	from baseline to 3 months
change score of 36-item Short-Form Health Survey Questionnaire	from baseline to 6 months
change score of 36-item Short-Form Health Survey Questionnaire	from baseline to 12 months
change score of MOS Sleep Scale	from baseline to 2 weeks
change score of MOS Sleep Scale	from baseline to 1 month
change score of MOS Sleep Scale	from baseline to 2 months
change score of MOS Sleep Scale	from baseline to 3 months
change score of MOS Sleep Scale	from baseline to 6 months
change score of MOS Sleep Scale	from baseline to 12 months
rate of ACR20	at 12 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 13, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Traditional Chinese medicine; methotrexate; active rheumatoid arthritis; Niu Bang Zi pill
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: Niubang Pill

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No