Juanbi PillPhase 2/3NCT02885597
Juanbi Pill for Rheumatoid Arthritis
A Phase 2/3 study testing Juanbi pill and Methotrexate in people with Juanbi Pill and Rheumatoid Arthritis, run by Cui xuejun at 1 site in China.
Trial summary
The purpose of this study is to determine whether Juanbi Pill combined with methotrexate are effective in the treatment of active Rheumatoid Arthritis (RA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Juanbi Pill, Rheumatoid Arthritis
- What is being tested?
- Juanbi pill and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Jul 2018to Dec 2020
- 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 University of TCM
Shanghai, Shanghai Municipality, 200032
Qianqian Liang, Doctor, 86-021-64875390, liangqianqiantcm@126.com
Qiong Wang, 86-13671779096, 13671779096@163.com
About this study
Official title: 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).
Read the 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.
- Conditions
- Juanbi Pill, Rheumatoid Arthritis
- Being tested
- Juanbi pill, Juanbi pill placebo, Methotrexate
- Keywords
- Juanbi Pill, Methotrexate, Active, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juanbi pillDrug
Also called Experimental: Juanbi group
4g, twice a day, 3month, oral
Juanbi pill placeboDrug
Also called Placebo Comparator: placebo group
4g, twice a day, 3month, oral
MethotrexateDrug
Also called Experimental: Juanbi group, Placebo Comparator: placebo group
5mg, once a week, 3 month, oral
| Study group | Role | What they receive |
|---|---|---|
| Juanbi group | Experimental | participants should administrate both Juanbi pill and Methotrexate Receives: Drug: Juanbi pill; Drug: Methotrexate |
| placebo group | Placebo comparator | participants should administrate both Juanbi pill placebo and Methotrexate Receives: Drug: Juanbi pill placebo; Drug: Methotrexate |
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 12 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: form baseline to 2 weeks
change score of 36-item Short-Form Health Survey Questionnaire
Measured: form baseline to 1 month
change score of 36-item Short-Form Health Survey Questionnaire
Measured: form baseline to 2 months
change score of 36-item Short-Form Health Survey Questionnaire
Measured: form baseline to 3 months
change score of 36-item Short-Form Health Survey Questionnaire
Measured: form baseline to 6 months
change score of 36-item Short-Form Health Survey Questionnaire
Measured: form baseline to 12 months
change score of AIS Sleep Scale
Measured: from baseline to 2 weeks
change score of AIS Sleep Scale
Measured: from baseline to 1 month
change score of AIS Sleep Scale
Measured: from baseline to 2 months
change score of AIS Sleep Scale
Measured: from baseline to 3 months
change score of AIS Sleep Scale
Measured: from baseline to 6 months
change score of AIS 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: 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 posted31 Aug 2016 (estimated)
- Study startJul 2018 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Juanbi 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cui xuejun
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Yueyang Integrated Medicine Hospital, Longhua Hospital, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
- Responsible party
- Sponsor-investigator, Cui xuejun, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885597
- Sponsor's protocol ID
- Juanbi pill
- Status last verified
- Jul 2018
- First submitted
- 18 Aug 2016
- 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
Jia QY, Wang YR, Sun DW, Mao JC, Xue L, Gu XH, Yu X, Piao XM, Xu H, Liang QQ. Efficacy and Safety of Juan Bi Pill with Add-on Methotrexate in Active Rheumatoid Arthritis: A 48-Week, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial. Chin J Integr Med. 2025 Feb;31(2):99-107. doi: 10.1007/s11655-024-3768-7. Epub 2024 Dec 21.
PubMed 39707138Wang 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.
PubMed 29558967
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
- Juanbi Pill Combined With Methotrexate for Rheumatoid Arthritis: Multi-center Random Controlled Clinical Trials
- ClinicalTrials.gov ID
- NCT02885597
- Acronym / sponsor ID
- Juanbi pill
- Conditions
- Juanbi Pill, Rheumatoid Arthritis
- Keywords
- Juanbi Pill, Methotrexate, Active, Rheumatoid Arthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cui xuejunUniversity, hospital or other
- Collaborators
- Shanghai Yueyang Integrated Medicine Hospital, Longhua Hospital, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
- Study start
- Jul 2018 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 31 Aug 2016 (estimated)
- 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.
The purpose of this study is to determine whether Juanbi Pill combined with methotrexate are effective in the treatment of active Rheumatoid Arthritis (RA).
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 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 |
|---|---|---|
| Juanbi group | Experimental | Drug: Juanbi pill, Drug: Methotrexateparticipants should administrate both Juanbi pill and Methotrexate |
| placebo group | Placebo comparator | Drug: Juanbi pill placebo, Drug: Methotrexateparticipants should administrate both Juanbi pill placebo 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 |
|---|---|---|
| Juanbi pillAlso: Experimental: Juanbi group4g, twice a day, 3month, oral | Drug | Juanbi group |
| Juanbi pill placeboAlso: Placebo Comparator: placebo group4g, twice a day, 3month, oral | Drug | placebo group |
| MethotrexateAlso: Experimental: Juanbi group, Placebo Comparator: placebo group5mg, once a week, 3 month, oral | Drug | Juanbi group, placebo 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 12 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: form baseline to 2 weeks
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: form baseline to 1 month
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: form baseline to 2 months
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: form baseline to 3 months
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: form baseline to 6 months
change score of 36-item Short-Form Health Survey Questionnaire
Time frame: form baseline to 12 months
change score of AIS Sleep Scale
Time frame: from baseline to 2 weeks
change score of AIS Sleep Scale
Time frame: from baseline to 1 month
change score of AIS Sleep Scale
Time frame: from baseline to 2 months
change score of AIS Sleep Scale
Time frame: from baseline to 3 months
change score of AIS Sleep Scale
Time frame: from baseline to 6 months
change score of AIS 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 39707138Jia QY, Wang YR, Sun DW, Mao JC, Xue L, Gu XH, Yu X, Piao XM, Xu H, Liang QQ. Efficacy and Safety of Juan Bi Pill with Add-on Methotrexate in Active Rheumatoid Arthritis: A 48-Week, Multicentre, Randomized, Double-Blind, Placebo-Controlled Trial. Chin J Integr Med. 2025 Feb;31(2):99-107. doi: 10.1007/s11655-024-3768-7. Epub 2024 Dec 21.
- Derived from this study: PubMed 29558967Wang 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.
- 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 testing Juanbi pill and Methotrexate in people with Juanbi 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 (86-189177763018, 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 NCT02885597, which also lists 2 linked publications.
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; AzTrials last refreshed its copy on 6 Nov 2026.