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

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ClinicalTrials.gov Identifier: NCT03173040
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : July 17, 2018
Sponsor:
Collaborators:
Shanghai Yueyang Integrated Medicine Hospital
Longhua Hospital
Shanghai Seventh People's Hospital
Information provided by (Responsible Party):
Cui xuejun, Shanghai University of Traditional Chinese Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Niu Bang Zi Pill Rheumatoid Arthritis Drug: NiuBangZi pill or NiuBangZi pill placebo Phase 2 Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NiuBangZi pill group
Drug: NiuBangZi pill (4g, twice a day, 3 months, oral) Drug: methotrexate (5mg, once a week, 3 months, oral) participants should administrate both NiuBangZi pill and methotrexate
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.

Placebo Comparator: Placeo group
Drug: NiuBangZi placebo pill (4g, twice a day, 3 months, oral) Drug: methotrexate (5mg, once a week, 3 months, oral) participants should administrate both NiuBangZi placebo pill and methotrexate
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.




Primary Outcome Measures :
  1. Rate of ACR (American College of Rheumatology) 50 [ Time Frame: at 3 months ]
  2. changes of The Disease Activity Score (DAS) 28 [ Time Frame: from baseline to 3 months ]
  3. changes of the van der Heijde modified Sharp score [ Time Frame: from baseline to 3 months ]

Secondary Outcome Measures :
  1. changes of The Disease Activity Score (DAS) 28 [ Time Frame: from baseline to 2 weeks ]
  2. changes of The Disease Activity Score (DAS) 28 [ Time Frame: from baseline to 1 month ]
  3. changes of The Disease Activity Score (DAS) 28 [ Time Frame: from baseline to 6 months ]
  4. changes of The Disease Activity Score (DAS) 28 [ Time Frame: from baseline to 12 months ]
  5. Rate of ACR (American College of Rheumatology) 50 [ Time Frame: at 2 weeks ]
  6. Rate of ACR (American College of Rheumatology) 50 [ Time Frame: at 1 month ]
  7. Rate of ACR (American College of Rheumatology) 50 [ Time Frame: at 2 months ]
  8. Rate of ACR (American College of Rheumatology) 50 [ Time Frame: at 6 months ]
  9. Rate of ACR (American College of Rheumatology) 50 [ Time Frame: at 12 months ]
  10. change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 2 weeks ]
  11. change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 1 month ]
  12. change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 2 months ]
  13. change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 3 months ]
  14. change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 6 months ]
  15. change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 12 months ]
  16. change score of Patient Assessment of Arthritis Pain [ Time Frame: from baseline to 2 weeks ]
  17. change score of Patient Assessment of Arthritis Pain [ Time Frame: from baseline to 1 month ]
  18. change score of Patient Assessment of Arthritis Pain [ Time Frame: from baseline to 2 months ]
  19. change score of Patient Assessment of Arthritis Pain [ Time Frame: from baseline to 3 months ]
  20. change score of Patient Assessment of Arthritis Pain [ Time Frame: from baseline to 6 months ]
  21. change score of Patient Assessment of Arthritis Pain [ Time Frame: from baseline to 12 months ]
  22. change score of Patient Global Assessment of Arthritis [ Time Frame: from baseline to 2 weeks ]
  23. change score of Patient Global Assessment of Arthritis [ Time Frame: from baseline to 1 month ]
  24. change score of Patient Global Assessment of Arthritis [ Time Frame: from baseline to 2 months ]
  25. change score of Patient Global Assessment of Arthritis [ Time Frame: from baseline to 3 months ]
  26. change score of Patient Global Assessment of Arthritis [ Time Frame: from baseline to 6 months ]
  27. change score of Patient Global Assessment of Arthritis [ Time Frame: from baseline to 12 months ]
  28. change score of 36-item Short-Form Health Survey Questionnaire [ Time Frame: from baseline to 2 weeks ]
  29. change score of 36-item Short-Form Health Survey Questionnaire [ Time Frame: from baseline to 1 month ]
  30. change score of 36-item Short-Form Health Survey Questionnaire [ Time Frame: from baseline to 2 months ]
  31. change score of 36-item Short-Form Health Survey Questionnaire [ Time Frame: from baseline to 3 months ]
  32. change score of 36-item Short-Form Health Survey Questionnaire [ Time Frame: from baseline to 6 months ]
  33. change score of 36-item Short-Form Health Survey Questionnaire [ Time Frame: from baseline to 12 months ]
  34. change score of MOS Sleep Scale [ Time Frame: from baseline to 2 weeks ]
  35. change score of MOS Sleep Scale [ Time Frame: from baseline to 1 month ]
  36. change score of MOS Sleep Scale [ Time Frame: from baseline to 2 months ]
  37. change score of MOS Sleep Scale [ Time Frame: from baseline to 3 months ]
  38. change score of MOS Sleep Scale [ Time Frame: from baseline to 6 months ]
  39. change score of MOS Sleep Scale [ Time Frame: from baseline to 12 months ]
  40. rate of ACR20 [ Time Frame: at 2 weeks ]
  41. rate of ACR20 [ Time Frame: at 1 month ]
  42. rate of ACR20 [ Time Frame: at 2 months ]
  43. rate of ACR20 [ Time Frame: at 3 months ]
  44. rate of ACR20 [ Time Frame: at 6 months ]
  45. rate of ACR20 [ Time Frame: at 12 months ]
  46. rate of ACR70 [ Time Frame: at 2 weeks ]
  47. rate of ACR70 [ Time Frame: at 1 month ]
  48. rate of ACR70 [ Time Frame: at 2 months ]
  49. rate of ACR70 [ Time Frame: at 3 months ]
  50. rate of ACR70 [ Time Frame: at 6 months ]
  51. rate of ACR70 [ Time Frame: at 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173040


Contacts
Contact: Yongjun Wang, Doctor 86-18917763018 yjwang8888@126.com
Contact: Qianqian Liang, Doctor 86-021-64875390

Locations
China, Shanghai
Longhua Hospital Recruiting
Shanghai, Shanghai, China
Contact: Qianqian Liang         
Sponsors and Collaborators
Cui xuejun
Shanghai Yueyang Integrated Medicine Hospital
Longhua Hospital
Shanghai Seventh People's Hospital

Responsible Party: Cui xuejun, Director, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03173040     History of Changes
Other Study ID Numbers: Niubang Pill
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cui xuejun, Shanghai University of Traditional Chinese Medicine:
Traditional Chinese medicine
Niu Bang Zi pill
methotrexate
active rheumatoid arthritis

Additional relevant MeSH terms:
Physiological Effects of Drugs
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors