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

Primary Purpose

Niu Bang Zi Pill, Rheumatoid Arthritis

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
NiuBangZi pill or NiuBangZi pill placebo
Sponsored by
Cui xuejun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Niu Bang Zi Pill focused on measuring Traditional Chinese medicine, Niu Bang Zi pill, methotrexate, active rheumatoid arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Longhua HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NiuBangZi pill group

Placeo group

Arm Description

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 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

Outcomes

Primary Outcome Measures

Rate of ACR (American College of Rheumatology) 50
changes of The Disease Activity Score (DAS) 28
changes of the van der Heijde modified Sharp score

Secondary Outcome Measures

changes of The Disease Activity Score (DAS) 28
changes of The Disease Activity Score (DAS) 28
changes of The Disease Activity Score (DAS) 28
changes of The Disease Activity Score (DAS) 28
Rate of ACR (American College of Rheumatology) 50
Rate of ACR (American College of Rheumatology) 50
Rate of ACR (American College of Rheumatology) 50
Rate of ACR (American College of Rheumatology) 50
Rate of ACR (American College of Rheumatology) 50
change score of Health Assessment Questionnaire - Disability Index
change score of Health Assessment Questionnaire - Disability Index
change score of Health Assessment Questionnaire - Disability Index
change score of Health Assessment Questionnaire - Disability Index
change score of Health Assessment Questionnaire - Disability Index
change score of Health Assessment Questionnaire - Disability Index
change score of Patient Assessment of Arthritis Pain
change score of Patient Assessment of Arthritis Pain
change score of Patient Assessment of Arthritis Pain
change score of Patient Assessment of Arthritis Pain
change score of Patient Assessment of Arthritis Pain
change score of Patient Assessment of Arthritis Pain
change score of Patient Global Assessment of Arthritis
change score of Patient Global Assessment of Arthritis
change score of Patient Global Assessment of Arthritis
change score of Patient Global Assessment of Arthritis
change score of Patient Global Assessment of Arthritis
change score of Patient Global Assessment of Arthritis
change score of 36-item Short-Form Health Survey Questionnaire
change score of 36-item Short-Form Health Survey Questionnaire
change score of 36-item Short-Form Health Survey Questionnaire
change score of 36-item Short-Form Health Survey Questionnaire
change score of 36-item Short-Form Health Survey Questionnaire
change score of 36-item Short-Form Health Survey Questionnaire
change score of MOS Sleep Scale
change score of MOS Sleep Scale
change score of MOS Sleep Scale
change score of MOS Sleep Scale
change score of MOS Sleep Scale
change score of MOS Sleep Scale
rate of ACR20
rate of ACR20
rate of ACR20
rate of ACR20
rate of ACR20
rate of ACR20
rate of ACR70
rate of ACR70
rate of ACR70
rate of ACR70
rate of ACR70
rate of ACR70

Full Information

First Posted
May 30, 2017
Last Updated
July 13, 2018
Sponsor
Cui xuejun
Collaborators
Shanghai Yueyang Integrated Medicine Hospital, Longhua Hospital, Shanghai 7th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03173040
Brief Title
The Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid Arthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cui xuejun
Collaborators
Shanghai Yueyang Integrated Medicine Hospital, Longhua Hospital, Shanghai 7th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Niu Bang Zi Pill, Rheumatoid Arthritis
Keywords
Traditional Chinese medicine, Niu Bang Zi pill, methotrexate, active rheumatoid arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NiuBangZi pill group
Arm Type
Experimental
Arm Description
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
Arm Title
Placeo group
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
NiuBangZi pill or NiuBangZi pill placebo
Intervention Description
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 Measure Information:
Title
Rate of ACR (American College of Rheumatology) 50
Time Frame
at 3 months
Title
changes of The Disease Activity Score (DAS) 28
Time Frame
from baseline to 3 months
Title
changes of the van der Heijde modified Sharp score
Time Frame
from baseline to 3 months
Secondary Outcome Measure Information:
Title
changes of The Disease Activity Score (DAS) 28
Time Frame
from baseline to 2 weeks
Title
changes of The Disease Activity Score (DAS) 28
Time Frame
from baseline to 1 month
Title
changes of The Disease Activity Score (DAS) 28
Time Frame
from baseline to 6 months
Title
changes of The Disease Activity Score (DAS) 28
Time Frame
from baseline to 12 months
Title
Rate of ACR (American College of Rheumatology) 50
Time Frame
at 2 weeks
Title
Rate of ACR (American College of Rheumatology) 50
Time Frame
at 1 month
Title
Rate of ACR (American College of Rheumatology) 50
Time Frame
at 2 months
Title
Rate of ACR (American College of Rheumatology) 50
Time Frame
at 6 months
Title
Rate of ACR (American College of Rheumatology) 50
Time Frame
at 12 months
Title
change score of Health Assessment Questionnaire - Disability Index
Time Frame
from baseline to 2 weeks
Title
change score of Health Assessment Questionnaire - Disability Index
Time Frame
from baseline to 1 month
Title
change score of Health Assessment Questionnaire - Disability Index
Time Frame
from baseline to 2 months
Title
change score of Health Assessment Questionnaire - Disability Index
Time Frame
from baseline to 3 months
Title
change score of Health Assessment Questionnaire - Disability Index
Time Frame
from baseline to 6 months
Title
change score of Health Assessment Questionnaire - Disability Index
Time Frame
from baseline to 12 months
Title
change score of Patient Assessment of Arthritis Pain
Time Frame
from baseline to 2 weeks
Title
change score of Patient Assessment of Arthritis Pain
Time Frame
from baseline to 1 month
Title
change score of Patient Assessment of Arthritis Pain
Time Frame
from baseline to 2 months
Title
change score of Patient Assessment of Arthritis Pain
Time Frame
from baseline to 3 months
Title
change score of Patient Assessment of Arthritis Pain
Time Frame
from baseline to 6 months
Title
change score of Patient Assessment of Arthritis Pain
Time Frame
from baseline to 12 months
Title
change score of Patient Global Assessment of Arthritis
Time Frame
from baseline to 2 weeks
Title
change score of Patient Global Assessment of Arthritis
Time Frame
from baseline to 1 month
Title
change score of Patient Global Assessment of Arthritis
Time Frame
from baseline to 2 months
Title
change score of Patient Global Assessment of Arthritis
Time Frame
from baseline to 3 months
Title
change score of Patient Global Assessment of Arthritis
Time Frame
from baseline to 6 months
Title
change score of Patient Global Assessment of Arthritis
Time Frame
from baseline to 12 months
Title
change score of 36-item Short-Form Health Survey Questionnaire
Time Frame
from baseline to 2 weeks
Title
change score of 36-item Short-Form Health Survey Questionnaire
Time Frame
from baseline to 1 month
Title
change score of 36-item Short-Form Health Survey Questionnaire
Time Frame
from baseline to 2 months
Title
change score of 36-item Short-Form Health Survey Questionnaire
Time Frame
from baseline to 3 months
Title
change score of 36-item Short-Form Health Survey Questionnaire
Time Frame
from baseline to 6 months
Title
change score of 36-item Short-Form Health Survey Questionnaire
Time Frame
from baseline to 12 months
Title
change score of MOS Sleep Scale
Time Frame
from baseline to 2 weeks
Title
change score of MOS Sleep Scale
Time Frame
from baseline to 1 month
Title
change score of MOS Sleep Scale
Time Frame
from baseline to 2 months
Title
change score of MOS Sleep Scale
Time Frame
from baseline to 3 months
Title
change score of MOS Sleep Scale
Time Frame
from baseline to 6 months
Title
change score of MOS Sleep Scale
Time Frame
from baseline to 12 months
Title
rate of ACR20
Time Frame
at 2 weeks
Title
rate of ACR20
Time Frame
at 1 month
Title
rate of ACR20
Time Frame
at 2 months
Title
rate of ACR20
Time Frame
at 3 months
Title
rate of ACR20
Time Frame
at 6 months
Title
rate of ACR20
Time Frame
at 12 months
Title
rate of ACR70
Time Frame
at 2 weeks
Title
rate of ACR70
Time Frame
at 1 month
Title
rate of ACR70
Time Frame
at 2 months
Title
rate of ACR70
Time Frame
at 3 months
Title
rate of ACR70
Time Frame
at 6 months
Title
rate of ACR70
Time Frame
at 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yongjun Wang, Doctor
Phone
86-18917763018
Email
yjwang8888@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qianqian Liang, Doctor
Phone
86-021-64875390
Facility Information:
Facility Name
Longhua Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qianqian Liang

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30732199
Citation
Wang YR, Liu L, Wang XY, Wang Q, Yao M, Cui XJ, Mao JC, Liu J, Gu XH, Chen YL, Yu X, Shi Q, Liang QQ, Wang YJ. The efficacy of the traditional Chinese medicine Jia Wei Niu Bang Zi granule combined with methotrexate in treating active rheumatoid arthritis: A multicenter, randomized, double-blinded controlled clinical trial. Medicine (Baltimore). 2019 Feb;98(6):e14424. doi: 10.1097/MD.0000000000014424.
Results Reference
derived

Learn more about this trial

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

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