Juanbi Pill for Rheumatoid Arthritis

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

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

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis; Juanbi Pill
• Intervention / Treatment: Drug: Juanbi pill; Drug: Methotrexate; Drug: Juanbi pill placebo

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Longhua Hospital, Shanghai university of TCM

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
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Juanbi group; participants should administrate both Juanbi pill and Methotrexate	Drug: Juanbi pill; 4g, twice a day, 3month, oral; Other Names: Experimental: Juanbi group; Drug: Methotrexate; 5mg, once a week, 3 month, oral; Other Names: Placebo Comparator: placebo group; Experimental: Juanbi group
PLACEBO_COMPARATOR: placebo group; participants should administrate both Juanbi pill placebo and Methotrexate	Drug: Methotrexate; 5mg, once a week, 3 month, oral; Other Names: Placebo Comparator: placebo group; Experimental: Juanbi group; Drug: Juanbi pill placebo; 4g, twice a day, 3month, oral; Other Names: Placebo Comparator: placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of ACR (American College Of Rheumatology) 50	at 3 months
changes of The Disease Activity Score (DAS) 28	from baseline to 3 months
changes of the van der Heijde modified Sharp score	from baseline to 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
change score of Patient Assessment of Arthritis Pain	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
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 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
change score of 36-item Short-Form Health Survey Questionnaire	form baseline to 2 weeks
change score of 36-item Short-Form Health Survey Questionnaire	form baseline to 1 month
change score of 36-item Short-Form Health Survey Questionnaire	form baseline to 2 months
change score of 36-item Short-Form Health Survey Questionnaire	form baseline to 3 months
change score of 36-item Short-Form Health Survey Questionnaire	form baseline to 6 months
change score of 36-item Short-Form Health Survey Questionnaire	form baseline to 12 months
change score of AIS Sleep Scale	from baseline to 2 weeks
change score of AIS Sleep Scale	from baseline to 1 month
change score of AIS Sleep Scale	from baseline to 2 months
change score of AIS Sleep Scale	from baseline to 3 months
change score of AIS Sleep Scale	from baseline to 6 months
change score of AIS Sleep Scale	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 ACR20	12 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

Collaborators and Investigators

• Sponsor: Cui xuejun
• Collaborators: Shanghai Yueyang Integrated Medicine Hospital; Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine; Longhua Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2018
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: August 18, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (ESTIMATE): August 31, 2016

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: Methotrexate; Rheumatoid Arthritis; Active; Juanbi Pill
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Methotrexate
• Other Study ID Numbers: Juanbi 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