Juanbi Pill for Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02885597
• Date of registration: 18/08/2016
• Prospective Registration: Yes
• Primary sponsor: Cui xuejun
• Public title: Juanbi Pill for Rheumatoid Arthritis
• Scientific title: Juanbi Pill Combined With Methotrexate for Rheumatoid Arthritis: Multi-center Random Controlled Clinical Trials
• Date of first enrolment: July 2018
• Target sample size: 120
• Recruitment status: Unknown status
• URL: https://clinicaltrials.gov/show/NCT02885597
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

China

Contacts

• Name: Yongjun Wang, Doctor

• Name: Qianqian Liang, Doctor

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Juanbi Pill

Intervention(s)

Drug: Methotrexate

Drug: Juanbi pill placebo

Drug: Juanbi pill

Primary Outcome(s)

changes of The Disease Activity Score (DAS) 28 [Time Frame: from baseline to 3 months]

Rate of ACR (American College Of Rheumatology) 50 [Time Frame: at 3 months]

changes of the van der Heijde modified Sharp score [Time Frame: from baseline to 12 months]

Secondary Outcome(s)

change score of 36-item Short-Form Health Survey Questionnaire [Time Frame: form baseline to 6 months]

change score of AIS Sleep Scale [Time Frame: from baseline to 1 month]

change score of 36-item Short-Form Health Survey Questionnaire [Time Frame: form baseline to 2 weeks]

change score of Patient Assessment of Arthritis Pain [Time Frame: from baseline to 6 months]

change score of AIS Sleep Scale [Time Frame: from baseline to 12 months]

change score of Health Assessment Questionnaire - Disability Index [Time Frame: from baseline to 2 weeks]

change score of Patient Global Assessment of Arthritis [Time Frame: from baseline to 2 months]

rate of ACR20 [Time Frame: 12 months]

change score of 36-item Short-Form Health Survey Questionnaire [Time Frame: form baseline to 1 month]

change score of AIS Sleep Scale [Time Frame: from baseline to 2 months]

change score of Patient Assessment of Arthritis Pain [Time Frame: from baseline to 2 months]

change score of Patient Assessment of Arthritis Pain [Time Frame: from baseline to 3 months]

change score of Health Assessment Questionnaire - Disability Index [Time Frame: from baseline to 2 months]

change score of Health Assessment Questionnaire - Disability Index [Time Frame: from baseline to 3 months]

change score of Patient Global Assessment of Arthritis [Time Frame: from baseline to 1 month]

changes of The Disease Activity Score (DAS) 28 [Time Frame: from baseline to 1 month]

change score of Patient Global Assessment of Arthritis [Time Frame: from baseline to 2 weeks]

changes of The Disease Activity Score (DAS) 28 [Time Frame: from baseline to 2 weeks]

Rate of ACR(American College Of Rheumatology)50 [Time Frame: at 1 month]

Rate of ACR(American College Of Rheumatology)50 [Time Frame: at 12 months]

rate of ACR70 [Time Frame: at 1 month]

rate of ACR70 [Time Frame: at 2 months]

change score of AIS Sleep Scale [Time Frame: from baseline to 3 months]

change score of AIS Sleep Scale [Time Frame: from baseline to 6 months]

change score of Patient Assessment of Arthritis Pain [Time Frame: from baseline to 2 weeks]

Rate of ACR(American College Of Rheumatology)50 [Time Frame: at 6 months]

change score of 36-item Short-Form Health Survey Questionnaire [Time Frame: form baseline to 12 months]

change score of Patient Assessment of Arthritis Pain [Time Frame: from baseline to 1 month]

change score of AIS Sleep Scale [Time Frame: from baseline to 2 weeks]

change score of Health Assessment Questionnaire - Disability Index [Time Frame: from baseline to 1 month]

change score of Health Assessment Questionnaire - Disability Index [Time Frame: from baseline to 12 months]

change score of Health Assessment Questionnaire - Disability Index [Time Frame: from baseline to 6 months]

change score of Patient Assessment of Arthritis Pain [Time Frame: from baseline to 12 months]

change score of Patient Global Assessment of Arthritis [Time Frame: from baseline to 3 months]

change score of Patient Global Assessment of Arthritis [Time Frame: from baseline to 12 months]

changes of The Disease Activity Score (DAS) 28 [Time Frame: from baseline to 12 months]

change score of Patient Global Assessment of Arthritis [Time Frame: from baseline to 6 months]

rate of ACR20 [Time Frame: at 1 month]

changes of The Disease Activity Score (DAS) 28 [Time Frame: from baseline to 6 months]

Rate of ACR(American College Of Rheumatology)50 [Time Frame: at 2 months]

Rate of ACR(American College Of Rheumatology)50 [Time Frame: at 2 weeks]

rate of ACR20 [Time Frame: at 2 weeks]

rate of ACR70 [Time Frame: at 2 weeks]

rate of ACR20 [Time Frame: at 2 months]

rate of ACR20 [Time Frame: at 6 months]

rate of ACR70 [Time Frame: at 3 months]

rate of ACR70 [Time Frame: at 6 months]

rate of ACR70 [Time Frame: at 12 months]

change score of 36-item Short-Form Health Survey Questionnaire [Time Frame: form baseline to 2 months]

change score of 36-item Short-Form Health Survey Questionnaire [Time Frame: form baseline to 3 months]

rate of ACR20 [Time Frame: at 3 months]

Secondary ID(s)

Juanbi pill

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Longhua Hospital

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Shanghai Yueyang Integrated Medicine Hospital