Juanbi Pill for Rheumatoid Arthritis

NCT ID: NCT02885597

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2020-12-31

Brief 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).

Detailed 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.

Conditions

Juanbi Pill; Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Juanbi group

participants should administrate both Juanbi pill and Methotrexate

Group Type: EXPERIMENTAL

Juanbi pill

Intervention Type: DRUG

4g, twice a day, 3month, oral

Methotrexate

Intervention Type: DRUG

5mg, once a week, 3 month, oral

placebo group

participants should administrate both Juanbi pill placebo and Methotrexate

Group Type: PLACEBO_COMPARATOR

Juanbi pill placebo

Intervention Type: DRUG

4g, twice a day, 3month, oral

Methotrexate

Intervention Type: DRUG

5mg, once a week, 3 month, oral

Interventions

Juanbi pill

4g, twice a day, 3month, oral

Intervention Type: DRUG

Juanbi pill placebo

4g, twice a day, 3month, oral

Intervention Type: DRUG

Methotrexate

5mg, once a week, 3 month, oral

Intervention Type: DRUG

Other Intervention Names

Experimental: Juanbi group; Placebo Comparator: placebo group; Experimental: Juanbi group; Placebo Comparator: placebo group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Yueyang Integrated Medicine Hospital

OTHER

Sponsor Role: collaborator

Longhua Hospital

OTHER

Sponsor Role: collaborator

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

OTHER

Sponsor Role: collaborator

Cui xuejun

OTHER

Sponsor Role: lead

Responsible Party

Cui xuejun

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Longhua Hospital, Shanghai University of TCM

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongjun Wang, Doctor

Role: CONTACT

yjwang8888@126.com

86-189177763018

Qianqian Liang, Doctor

Role: CONTACT

86-021-64875390

Facility Contacts

Qianqian Liang, Doctor

Role: primary

liangqianqiantcm@126.com

86-021-64875390

Qiong Wang

Role: backup

13671779096@163.com

86-13671779096

References

Jia QY, Wang YR, Sun DW, Mao JC, Xue L, Gu XH, Yu X, Piao XM, Xu H, Liang QQ. Efficacy and Safety of Juan Bi Pill with Add-on Methotrexate in Active Rheumatoid Arthritis: A 48-Week, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial. Chin J Integr Med. 2025 Feb;31(2):99-107. doi: 10.1007/s11655-024-3768-7. Epub 2024 Dec 21.

Reference Type: DERIVED

PMID: 39707138 (View on PubMed)

Wang Q, Wang YR, Jia QY, Liu L, Xu CQ, Wang XY, Yao M, Cui XJ, Shi Q, Wang YJ, Liang QQ. The efficacy of the traditional Chinese medicine Juanbi pill combined with methotrexate in active rheumatoid arthritis: study protocol for a randomized controlled trial. Trials. 2018 Mar 20;19(1):188. doi: 10.1186/s13063-018-2555-1.

Reference Type: DERIVED

PMID: 29558967 (View on PubMed)

Other Identifiers

Juanbi pill

Identifier Type: -

Identifier Source: org_study_id