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

July 13, 2018 updated by: Cui xuejun

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Longhua Hospital
        • Contact:
          • Qianqian Liang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
changes of The Disease Activity Score (DAS) 28
Time Frame: from baseline to 3 months
from baseline to 3 months
Rate of ACR (American College of Rheumatology) 50
Time Frame: at 3 months
at 3 months
changes of the van der Heijde modified Sharp score
Time Frame: from baseline to 3 months
from baseline to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
change score of Patient Assessment of Arthritis Pain
Time Frame: from baseline to 2 weeks
from baseline to 2 weeks
change score of 36-item Short-Form Health Survey Questionnaire
Time Frame: from baseline to 2 weeks
from baseline to 2 weeks
rate of ACR20
Time Frame: at 2 weeks
at 2 weeks
changes of The Disease Activity Score (DAS) 28
Time Frame: from baseline to 2 weeks
from baseline to 2 weeks
changes of The Disease Activity Score (DAS) 28
Time Frame: from baseline to 1 month
from baseline to 1 month
changes of The Disease Activity Score (DAS) 28
Time Frame: from baseline to 6 months
from baseline to 6 months
changes of The Disease Activity Score (DAS) 28
Time Frame: from baseline to 12 months
from baseline to 12 months
change score of Health Assessment Questionnaire - Disability Index
Time Frame: from baseline to 2 weeks
from baseline to 2 weeks
change score of Health Assessment Questionnaire - Disability Index
Time Frame: from baseline to 1 month
from baseline to 1 month
change score of Health Assessment Questionnaire - Disability Index
Time Frame: from baseline to 2 months
from baseline to 2 months
change score of Health Assessment Questionnaire - Disability Index
Time Frame: from baseline to 3 months
from baseline to 3 months
change score of Health Assessment Questionnaire - Disability Index
Time Frame: from baseline to 6 months
from baseline to 6 months
change score of Health Assessment Questionnaire - Disability Index
Time Frame: from baseline to 12 months
from baseline to 12 months
change score of Patient Assessment of Arthritis Pain
Time Frame: from baseline to 1 month
from baseline to 1 month
change score of Patient Assessment of Arthritis Pain
Time Frame: from baseline to 2 months
from baseline to 2 months
change score of Patient Assessment of Arthritis Pain
Time Frame: from baseline to 3 months
from baseline to 3 months
change score of Patient Assessment of Arthritis Pain
Time Frame: from baseline to 6 months
from baseline to 6 months
change score of Patient Assessment of Arthritis Pain
Time Frame: from baseline to 12 months
from baseline to 12 months
change score of Patient Global Assessment of Arthritis
Time Frame: from baseline to 2 weeks
from baseline to 2 weeks
change score of Patient Global Assessment of Arthritis
Time Frame: from baseline to 1 month
from baseline to 1 month
change score of Patient Global Assessment of Arthritis
Time Frame: from baseline to 2 months
from baseline to 2 months
change score of Patient Global Assessment of Arthritis
Time Frame: from baseline to 3 months
from baseline to 3 months
change score of Patient Global Assessment of Arthritis
Time Frame: from baseline to 6 months
from baseline to 6 months
change score of Patient Global Assessment of Arthritis
Time Frame: from baseline to 12 months
from baseline to 12 months
rate of ACR20
Time Frame: at 1 month
at 1 month
rate of ACR20
Time Frame: at 2 months
at 2 months
rate of ACR20
Time Frame: at 3 months
at 3 months
rate of ACR20
Time Frame: at 6 months
at 6 months
rate of ACR70
Time Frame: at 2 weeks
at 2 weeks
rate of ACR70
Time Frame: at 1 month
at 1 month
rate of ACR70
Time Frame: at 2 months
at 2 months
rate of ACR70
Time Frame: at 3 months
at 3 months
rate of ACR70
Time Frame: at 6 months
at 6 months
rate of ACR70
Time Frame: at 12 months
at 12 months
Rate of ACR (American College of Rheumatology) 50
Time Frame: at 2 weeks
at 2 weeks
Rate of ACR (American College of Rheumatology) 50
Time Frame: at 1 month
at 1 month
Rate of ACR (American College of Rheumatology) 50
Time Frame: at 2 months
at 2 months
Rate of ACR (American College of Rheumatology) 50
Time Frame: at 6 months
at 6 months
Rate of ACR (American College of Rheumatology) 50
Time Frame: at 12 months
at 12 months
change score of 36-item Short-Form Health Survey Questionnaire
Time Frame: from baseline to 1 month
from baseline to 1 month
change score of 36-item Short-Form Health Survey Questionnaire
Time Frame: from baseline to 2 months
from baseline to 2 months
change score of 36-item Short-Form Health Survey Questionnaire
Time Frame: from baseline to 3 months
from baseline to 3 months
change score of 36-item Short-Form Health Survey Questionnaire
Time Frame: from baseline to 6 months
from baseline to 6 months
change score of 36-item Short-Form Health Survey Questionnaire
Time Frame: from baseline to 12 months
from baseline to 12 months
change score of MOS Sleep Scale
Time Frame: from baseline to 2 weeks
from baseline to 2 weeks
change score of MOS Sleep Scale
Time Frame: from baseline to 1 month
from baseline to 1 month
change score of MOS Sleep Scale
Time Frame: from baseline to 2 months
from baseline to 2 months
change score of MOS Sleep Scale
Time Frame: from baseline to 3 months
from baseline to 3 months
change score of MOS Sleep Scale
Time Frame: from baseline to 6 months
from baseline to 6 months
change score of MOS Sleep Scale
Time Frame: from baseline to 12 months
from baseline to 12 months
rate of ACR20
Time Frame: at 12 months
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cui xuejun

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Yueyang Integrated Medicine Hospital
Longhua Hospital
Shanghai Seventh People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Niubang 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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