Niu Bang Zi PillPhase 2/3NCT03173040
The Efficacy of the Traditional Chinese Medicine Niubang Pill Combined With Methotrexate on Active Rheumatoid Arthritis
A Phase 2/3 study of Niu Bang Zi Pill and Rheumatoid Arthritis, run by Cui xuejun at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Niu Bang Zi Pill, Rheumatoid Arthritis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jul 2018to Dec 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Qianqian Liang, Doctor contact
China1 site, 1 recruiting
- Recruiting
Longhua Hospital
Shanghai, Shanghai Municipality
Qianqian Liang
About this study
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
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.
Read the 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.
- Conditions
- Niu Bang Zi Pill, Rheumatoid Arthritis
- Being tested
- NiuBangZi pill or NiuBangZi pill placebo
- Keywords
- Traditional Chinese medicine, Niu Bang Zi pill, methotrexate, active rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiuBangZi pill or NiuBangZi pill placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| NiuBangZi pill group | Experimental | 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 Receives: Drug: NiuBangZi pill or NiuBangZi pill placebo |
| Placeo group | Placebo comparator | 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 Receives: Drug: NiuBangZi pill or NiuBangZi pill placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of ACR (American College of Rheumatology) 50
Measured: at 3 months
changes of The Disease Activity Score (DAS) 28
Measured: from baseline to 3 months
changes of the van der Heijde modified Sharp score
Measured: from baseline to 3 months
Secondary outcomes (51)
changes of The Disease Activity Score (DAS) 28
Measured: from baseline to 2 weeks
changes of The Disease Activity Score (DAS) 28
Measured: from baseline to 1 month
changes of The Disease Activity Score (DAS) 28
Measured: from baseline to 6 months
changes of The Disease Activity Score (DAS) 28
Measured: from baseline to 12 months
Rate of ACR (American College of Rheumatology) 50
Measured: at 2 weeks
Rate of ACR (American College of Rheumatology) 50
Measured: at 1 month
Rate of ACR (American College of Rheumatology) 50
Measured: at 2 months
Rate of ACR (American College of Rheumatology) 50
Measured: at 6 months
Rate of ACR (American College of Rheumatology) 50
Measured: at 12 months
change score of Health Assessment Questionnaire - Disability Index
Measured: from baseline to 2 weeks
change score of Health Assessment Questionnaire - Disability Index
Measured: from baseline to 1 month
change score of Health Assessment Questionnaire - Disability Index
Measured: from baseline to 2 months
change score of Health Assessment Questionnaire - Disability Index
Measured: from baseline to 3 months
change score of Health Assessment Questionnaire - Disability Index
Measured: from baseline to 6 months
change score of Health Assessment Questionnaire - Disability Index
Measured: from baseline to 12 months
change score of Patient Assessment of Arthritis Pain
Measured: from baseline to 2 weeks
change score of Patient Assessment of Arthritis Pain
Measured: from baseline to 1 month
change score of Patient Assessment of Arthritis Pain
Measured: from baseline to 2 months
change score of Patient Assessment of Arthritis Pain
Measured: from baseline to 3 months
change score of Patient Assessment of Arthritis Pain
Measured: from baseline to 6 months
change score of Patient Assessment of Arthritis Pain
Measured: from baseline to 12 months
change score of Patient Global Assessment of Arthritis
Measured: from baseline to 2 weeks
change score of Patient Global Assessment of Arthritis
Measured: from baseline to 1 month
change score of Patient Global Assessment of Arthritis
Measured: from baseline to 2 months
change score of Patient Global Assessment of Arthritis
Measured: from baseline to 3 months
change score of Patient Global Assessment of Arthritis
Measured: from baseline to 6 months
change score of Patient Global Assessment of Arthritis
Measured: from baseline to 12 months
change score of 36-item Short-Form Health Survey Questionnaire
Measured: from baseline to 2 weeks
change score of 36-item Short-Form Health Survey Questionnaire
Measured: from baseline to 1 month
change score of 36-item Short-Form Health Survey Questionnaire
Measured: from baseline to 2 months
change score of 36-item Short-Form Health Survey Questionnaire
Measured: from baseline to 3 months
change score of 36-item Short-Form Health Survey Questionnaire
Measured: from baseline to 6 months
change score of 36-item Short-Form Health Survey Questionnaire
Measured: from baseline to 12 months
change score of MOS Sleep Scale
Measured: from baseline to 2 weeks
change score of MOS Sleep Scale
Measured: from baseline to 1 month
change score of MOS Sleep Scale
Measured: from baseline to 2 months
change score of MOS Sleep Scale
Measured: from baseline to 3 months
change score of MOS Sleep Scale
Measured: from baseline to 6 months
change score of MOS Sleep Scale
Measured: from baseline to 12 months
rate of ACR20
Measured: at 2 weeks
rate of ACR20
Measured: at 1 month
rate of ACR20
Measured: at 2 months
rate of ACR20
Measured: at 3 months
rate of ACR20
Measured: at 6 months
rate of ACR20
Measured: at 12 months
rate of ACR70
Measured: at 2 weeks
rate of ACR70
Measured: at 1 month
rate of ACR70
Measured: at 2 months
rate of ACR70
Measured: at 3 months
rate of ACR70
Measured: at 6 months
rate of ACR70
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study startJul 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Niu Bang Zi PillStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cui xuejun
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Yueyang Integrated Medicine Hospital, Longhua Hospital, Shanghai 7th People's Hospital
- Responsible party
- Sponsor-investigator, Cui xuejun, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173040
- Sponsor's protocol ID
- Niubang Pill
- Status last verified
- Jul 2018
- First submitted
- 30 May 2017
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30732199
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03173040
- Acronym / sponsor ID
- Niubang Pill
- Conditions
- Niu Bang Zi Pill, Rheumatoid Arthritis
- Keywords
- Traditional Chinese medicine, Niu Bang Zi pill, methotrexate, active rheumatoid arthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cui xuejunUniversity, hospital or other
- Collaborators
- Shanghai Yueyang Integrated Medicine Hospital, Longhua Hospital, Shanghai 7th People's Hospital
- Study start
- Jul 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NiuBangZi pill group | Experimental | Drug: NiuBangZi pill or NiuBangZi pill placeboDrug: 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 |
| Placeo group | Placebo comparator | Drug: NiuBangZi pill or NiuBangZi pill placeboDrug: 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiuBangZi pill or NiuBangZi pill placeboFor 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. | Drug | NiuBangZi pill group, Placeo group |
Primary outcome
Rate of ACR (American College of Rheumatology) 50
Time frame: at 3 months
changes of The Disease Activity Score (DAS) 28
Time frame: from baseline to 3 months
changes of the van der Heijde modified Sharp score
Time frame: from baseline to 3 months
51 secondary outcomes
changes of The Disease Activity Score (DAS) 28
Time frame: from baseline to 2 weeks
changes of The Disease Activity Score (DAS) 28
Time frame: from baseline to 1 month
changes of The Disease Activity Score (DAS) 28
Time frame: from baseline to 6 months
changes of The Disease Activity Score (DAS) 28
Time frame: from baseline to 12 months
Rate of ACR (American College of Rheumatology) 50
Time frame: at 2 weeks
Rate of ACR (American College of Rheumatology) 50
Time frame: at 1 month
Rate of ACR (American College of Rheumatology) 50
Time frame: at 2 months
Rate of ACR (American College of Rheumatology) 50
Time frame: at 6 months
Rate of ACR (American College of Rheumatology) 50
Time frame: at 12 months
change score of Health Assessment Questionnaire - Disability Index
Time frame: from baseline to 2 weeks
change score of Health Assessment Questionnaire - Disability Index
Time frame: from baseline to 1 month
change score of Health Assessment Questionnaire - Disability Index
Time frame: from baseline to 2 months
change score of Health Assessment Questionnaire - Disability Index
Time frame: from baseline to 3 months
change score of Health Assessment Questionnaire - Disability Index
Time frame: from baseline to 6 months
change score of Health Assessment Questionnaire - Disability Index
Time frame: from baseline to 12 months
change score of Patient Assessment of Arthritis Pain
Time frame: from baseline to 2 weeks
change score of Patient Assessment of Arthritis Pain
Time frame: from baseline to 1 month
change score of Patient Assessment of Arthritis Pain
Time frame: from baseline to 2 months
change score of Patient Assessment of Arthritis Pain
Time frame: from baseline to 3 months
change score of Patient Assessment of Arthritis Pain
Time frame: from baseline to 6 months
change score of Patient Assessment of Arthritis Pain
Time frame: from baseline to 12 months
change score of Patient Global Assessment of Arthritis
Time frame: from baseline to 2 weeks
change score of Patient Global Assessment of Arthritis
Time frame: from baseline to 1 month
change score of Patient Global Assessment of Arthritis
Time frame: from baseline to 2 months
change score of Patient Global Assessment of Arthritis
Time frame: from baseline to 3 months
change score of Patient Global Assessment of Arthritis
Time frame: from baseline to 6 months
change score of Patient Global Assessment of Arthritis
Time frame: from baseline to 12 months
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: from baseline to 2 weeks
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: from baseline to 1 month
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: from baseline to 2 months
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: from baseline to 3 months
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: from baseline to 6 months
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: from baseline to 12 months
change score of MOS Sleep Scale
Time frame: from baseline to 2 weeks
change score of MOS Sleep Scale
Time frame: from baseline to 1 month
change score of MOS Sleep Scale
Time frame: from baseline to 2 months
change score of MOS Sleep Scale
Time frame: from baseline to 3 months
change score of MOS Sleep Scale
Time frame: from baseline to 6 months
change score of MOS Sleep Scale
Time frame: from baseline to 12 months
rate of ACR20
Time frame: at 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Derived from this study: PubMed 30732199Wang 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qianqian Liang, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study of Niu Bang Zi Pill and Rheumatoid Arthritis, run by Cui xuejun at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongjun Wang, Doctor (86-18917763018, yjwang8888@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of ACR (American College of Rheumatology) 50 (time frame: at 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03173040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.