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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03173040
• Other study ID #: Niubang Pill
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 2018
• Est. completion date: December 2018

Study information

• Verified date: July 2018
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Yongjun Wang, Doctor
• Phone: 86-18917763018
• Email: yjwang8888[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Niu Bang Zi Pill
• Rheumatoid Arthritis

Intervention

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.

Locations

Country	Name	City	State
China	Longhua Hospital	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Cui xuejun	Longhua Hospital, Shanghai Seventh People's Hospital, Shanghai Yueyang Integrated Medicine Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of ACR (American College of Rheumatology) 50		at 3 months
Primary	changes of The Disease Activity Score (DAS) 28		from baseline to 3 months
Primary	changes of the van der Heijde modified Sharp score		from baseline to 3 months
Secondary	changes of The Disease Activity Score (DAS) 28		from baseline to 2 weeks
Secondary	changes of The Disease Activity Score (DAS) 28		from baseline to 1 month
Secondary	changes of The Disease Activity Score (DAS) 28		from baseline to 6 months
Secondary	changes of The Disease Activity Score (DAS) 28		from baseline to 12 months
Secondary	Rate of ACR (American College of Rheumatology) 50		at 2 weeks
Secondary	Rate of ACR (American College of Rheumatology) 50		at 1 month
Secondary	Rate of ACR (American College of Rheumatology) 50		at 2 months
Secondary	Rate of ACR (American College of Rheumatology) 50		at 6 months
Secondary	Rate of ACR (American College of Rheumatology) 50		at 12 months
Secondary	change score of Health Assessment Questionnaire - Disability Index		from baseline to 2 weeks
Secondary	change score of Health Assessment Questionnaire - Disability Index		from baseline to 1 month
Secondary	change score of Health Assessment Questionnaire - Disability Index		from baseline to 2 months
Secondary	change score of Health Assessment Questionnaire - Disability Index		from baseline to 3 months
Secondary	change score of Health Assessment Questionnaire - Disability Index		from baseline to 6 months
Secondary	change score of Health Assessment Questionnaire - Disability Index		from baseline to 12 months
Secondary	change score of Patient Assessment of Arthritis Pain		from baseline to 2 weeks
Secondary	change score of Patient Assessment of Arthritis Pain		from baseline to 1 month
Secondary	change score of Patient Assessment of Arthritis Pain		from baseline to 2 months
Secondary	change score of Patient Assessment of Arthritis Pain		from baseline to 3 months
Secondary	change score of Patient Assessment of Arthritis Pain		from baseline to 6 months
Secondary	change score of Patient Assessment of Arthritis Pain		from baseline to 12 months
Secondary	change score of Patient Global Assessment of Arthritis		from baseline to 2 weeks
Secondary	change score of Patient Global Assessment of Arthritis		from baseline to 1 month
Secondary	change score of Patient Global Assessment of Arthritis		from baseline to 2 months
Secondary	change score of Patient Global Assessment of Arthritis		from baseline to 3 months
Secondary	change score of Patient Global Assessment of Arthritis		from baseline to 6 months
Secondary	change score of Patient Global Assessment of Arthritis		from baseline to 12 months
Secondary	change score of 36-item Short-Form Health Survey Questionnaire		from baseline to 2 weeks
Secondary	change score of 36-item Short-Form Health Survey Questionnaire		from baseline to 1 month
Secondary	change score of 36-item Short-Form Health Survey Questionnaire		from baseline to 2 months
Secondary	change score of 36-item Short-Form Health Survey Questionnaire		from baseline to 3 months
Secondary	change score of 36-item Short-Form Health Survey Questionnaire		from baseline to 6 months
Secondary	change score of 36-item Short-Form Health Survey Questionnaire		from baseline to 12 months
Secondary	change score of MOS Sleep Scale		from baseline to 2 weeks
Secondary	change score of MOS Sleep Scale		from baseline to 1 month
Secondary	change score of MOS Sleep Scale		from baseline to 2 months
Secondary	change score of MOS Sleep Scale		from baseline to 3 months
Secondary	change score of MOS Sleep Scale		from baseline to 6 months
Secondary	change score of MOS Sleep Scale		from baseline to 12 months
Secondary	rate of ACR20		at 2 weeks
Secondary	rate of ACR20		at 1 month
Secondary	rate of ACR20		at 2 months
Secondary	rate of ACR20		at 3 months
Secondary	rate of ACR20		at 6 months
Secondary	rate of ACR20		at 12 months
Secondary	rate of ACR70		at 2 weeks
Secondary	rate of ACR70		at 1 month
Secondary	rate of ACR70		at 2 months
Secondary	rate of ACR70		at 3 months
Secondary	rate of ACR70		at 6 months
Secondary	rate of ACR70		at 12 months