Juanbi Pill for Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Juanbi Pill Combined With Methotrexate for Rheumatoid Arthritis: Multi-center Random Controlled Clinical Trials

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02885597
• Other study ID #: Juanbi pill
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 2018
• Est. completion date: December 2020

Study information

• Verified date: July 2018
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Yongjun Wang, Doctor
• Phone: 86-189177763018
• Email: yjwang8888[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Juanbi Pill combined with methotrexate are effective in the treatment of active Rheumatoid Arthritis (RA).

Description:

Rheumatoid arthritis patients are suffering from painful and swelling of joints as well as joint destruction and functional disability with the duration of disease activity. Patients and physician try to find a way to alleviate the swell and tenderness of joints to avoid irreversible joints impairment, for evidence indicating that early aggressive treatment results in greater improvement than therapy initiated later in the disease course.

As a complementary and alternative medicine (CAM), herbal medicines have the potential to achieve a clinical remission, or push the disease back to low disease activity. In traditional Chinese medicine (TCM), rheumatoid arthritis is a Bi syndrome and Juanbi decotion (notopterygium root, radix angelicae pubescentis, Gentiana macrophylla, Kadsura Pepper Stem, Mulberry Twig, Angelica sinensis, Ligusticum wallichii, frankincense, Radix Aucklandiae, shaved cinnamon barka and liquorice ) is a medicine specially for Bi syndrome and it has been used in Chinese for hundreds of years. Juanbi pill is the raw extration of Juanbi decotion for the sake of convenience of quality control and storage.

Although the long term usage of Juanbi decotion, there is no high quality evidence about the decotion on rheumatoid arthritis. Using a well-designed clinical trial, the investigators will survey the effectiveness of concurrent use of this decotion in relieving disease activity. Therefore, the present study is to examine effectiveness and safety of Juanbi Pill, a compound traditional Chinese herbal medicine on rheumatoid arthritis in a randomized, double-blind, placebo-controlled trial. Results of this study will provide evidence regarding the value of the Juanbi pill as an intervention to lower the disease activity and protect the affected joints from deformity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2020
• 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
• Juanbi Pill
• Rheumatoid Arthritis

Intervention

Drug:
• Juanbi pill
4g, twice a day, 3month, oral
• Juanbi pill placebo
4g, twice a day, 3month, oral
• Methotrexate
5mg, once a week, 3 month, oral

Locations

Country	Name	City	State
China	Longhua Hospital, Shanghai University of TCM	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Cui xuejun	Longhua Hospital, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, 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 12 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		form baseline to 2 weeks
Secondary	change score of 36-item Short-Form Health Survey Questionnaire		form baseline to 1 month
Secondary	change score of 36-item Short-Form Health Survey Questionnaire		form baseline to 2 months
Secondary	change score of 36-item Short-Form Health Survey Questionnaire		form baseline to 3 months
Secondary	change score of 36-item Short-Form Health Survey Questionnaire		form baseline to 6 months
Secondary	change score of 36-item Short-Form Health Survey Questionnaire		form baseline to 12 months
Secondary	change score of AIS Sleep Scale		from baseline to 2 weeks
Secondary	change score of AIS Sleep Scale		from baseline to 1 month
Secondary	change score of AIS Sleep Scale		from baseline to 2 months
Secondary	change score of AIS Sleep Scale		from baseline to 3 months
Secondary	change score of AIS Sleep Scale		from baseline to 6 months
Secondary	change score of AIS 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		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