Rheumatoid Arthritis (RA)Phase 2/3CHARMSNCT07627893
Complementary Herbal Approach to Rheumatoid Management Study (CHARMS)
A Phase 2/3 study testing Shu Bi Ning (modified Si Miao Xiao Bi) and Methotrexate in people with Rheumatoid Arthritis (RA), run by Singapore General Hospital at 1 site in Singapore.
Trial summary
Rheumatoid Arthritis (RA) is a chronic disease characterised by symmetric, polyarticular pain and swelling, involving small joints of the hands and feet. RA can lead to irreversible joint damage without treatment, causing disability and impacting daily activities and work productivity. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- Shu Bi Ning (modified Si Miao Xiao Bi) and Methotrexate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jun 2026to 30 Jun 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between the ages of 21 and 70 years, and diagnosed with RA by a rheumatologist and fulfilling the 2010 ACR/EULAR classification criteria for RA.
- Active disease with DAS28 ESR ≥3.2 at screening, with at least 6 swollen joints out of 66 and at least 6 tender joints out of 68.
- Receiving stable doses of methotrexate therapy for at least 3 months, and on stable dose for at least 4 weeks before trial entry ( ≥10mg per week), either subcutaneous or orally.
- Stable doses of non-steroidal anti-inflammatory drugs (NSAIDS), acetaminophen, or oral corticosteroids (equivalent to prednisone ≤ 10 mg) for at least 4 weeks prior to first dose of study medication.
- Except for methotrexate, patients must have discontinued all csDMARDs, including, but not limited to: hydroxychloroquine, sulfasalazine, leflunomide prior to first dose of study medication as specified below:
- ≥ 4 weeks prior to Baseline Visit for sulfasalazine and hydroxychloroquine
Show all 9Show fewer
- ≥ 8 weeks prior to Baseline Visit for leflunomide if no elimination procedure was followed, or adhere to an elimination procedure (i.e., 11 days with cholestyramine, or 30 days washout with activated charcoal)
- A negative urine pregnancy test for women of childbearing potential on Day 1 (prior to administration of first dose of study drug).
- Use of a reliable method of contraception by all female patients of childbearing potential and male patients with procreative capacity during the study and up to 3 months after the last dose of the study medication.
Who cannot join
- Not able to provide informed consent.
- Previous lack of efficacy to Si Miao Xiao Bi Tang.
- History of inflammatory joint disease other than RA. Secondary Sjogren's Syndrome is permitted.
- Concurrent use of other immunosuppressant medications, except MTX and protocol allowed doses of steroids.
- Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point administration of corticosteroids in the preceding 4 weeks prior to the Baseline Visit.
- Subject has been treated with any investigational drug within a minimum of 30 days or five half-lives (whichever is longer) of the drug prior to the Baseline Visit or is currently enrolling in another clinical study.
Show all 22Show fewer
- Pregnant or breastfeeding females.
- Infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses, untreated malignancy, or evidence of active or untreated latent tuberculosis.
- Receipt of any live vaccine within 1 month prior to the Screening Visit, or expected need of live vaccination during study participation including up to 1 month after the last dose of study drug.
- History of clinically significant hematologic, pulmonary, renal, hepatic, or psychiatric disease that would interfere with the subject's participation in this study.
- Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Day 1 or oral anti-infectives within 14 days prior to the Baseline Visit.
- Any uncontrolled clinically significant laboratory abnormality or any of the following laboratory abnormalities:
- Evidence of hematopoietic disorder or hemoglobin <9 g/dL
- White blood cell count <3.0 x 10^9/L (<3000/mm^3)
- Absolute neutrophil count <1.2 x 10^9/L (<1000/mm^3)
- Platelet count <100 x 10^9/L (<100,000/mm^3)
- Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) greater than 1.5 times the upper limit of normal (ULN)
- Estimated glomerular filtration rate of less than 60 mL/min
- Any arrhythmia on baseline/screening ECG.
- Females of childbearing potential not willing to use contraceptive methods which, in the opinion of the investigator, are effective and adequate while on the study. Female subjects who are not of childbearing potential must meet at least one of the following criteria: (a) Have undergone a documented hysterectomy and/or bilateral oophorectomy; or (b) Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause.
- Been diagnosed with G6PD deficiency.
- Subjects who are taking TCM supplements regularly (daily) and not willing to stop intake.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169608
About this study
Rheumatoid Arthritis (RA) is a chronic disease characterised by symmetric, polyarticular pain and swelling, involving small joints of the hands and feet. RA can lead to irreversible joint damage without treatment, causing disability and impacting daily activities and work productivity. Some patients turn to Chinese Herbal Medication (CHM) for treatment. Since there is currently no well designed randomised controlled trial to support the 'real-world' use of Si Miao Xiao Bi Tang with anti-rheumatic drugs, such as methotrexate, the investigators are conducting a 12-week, randomised double-blinded placebo-controlled trial to determine the efficacy, safety and cost effectiveness of a modified Si Miao Xiao Bi Tang, a type of CHM, in the treatment of patients with active RA.
Read the detailed description
From the Traditional Chinese Medicine (TCM) perspective, RA is part of the Bi Syndrome. Si Miao Xiao Bi Tang is one of the formulas listed in the guidelines for treatment of Damp-Heat syndrome. Till date, few studies have explored use of CHM, in particular Si Miao Xiao Bi Tang, in treating RA. According to past systematic reviews of radnomised controlled trials performed on Chinese herbs in RA patients, most studies were of low methodological quality and small numbers, resulting in lack of generalizability. Studies looking into cost effectiveness are also lacking.
Proposed project is a randomised double-blind placebo-controlled trial to be conducted over a period of three years, anchored to the Consolidated Standards of Reporting Trials (CONSORT) guidelines and CONSORT extension for CHM. Eligible patients will be randomly allocated to receive CHM and methotrexate or methotrexate and placebo on a 1:1 basis via random permuted block randomization.
Intervention group and control group patients receive methotrexate and CHM or methotrexate and placebo respectively for 12 weeks. They will attend rheumatologist reviews at weeks 0, 4, 8, and 12, including physical exams and disease monitoring. Safety is tracked through blood tests, and further tests are ordered as needed. TCM physicians participate by counselling and diagnosing TCM syndrome and monitoring for side effects during study visits at weeks 0, 4, 8 and 12.
American College of Rheumatology 20% improvement criteria (ACR20) at week 8 is the primary outcome. To achieve an ACR20 response, a patient with RA must demonstrate a 20% improvement in both tender and swollen joint counts, and 20% improvement in at least three of the following five criteria: patient's assessment of disease activity, physician's assessment of treatment response, patient's ability to perform daily activities based on Health Assessment Questionnaire-Disability Index (HAQ-DI), pain level, and serum inflammation markers.
Secondary outcomes include ACR20 response ACR50 response, ACR70 response, 28-joint disease activity score using ESR (DAS28-ESR), impact of RA on disability as measured using the Health Assessment Questionnaire Disability Index (HAQ-DI), severity of synovitis as determined using the EULAR-OMERACT ultrasound scoring system, quality of life as measured using the Medical Outcomes Study Short-Form (36-item) Health Survey (SF-36), fatigue level as measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale and safety of the trial.
Exploratory outcome is improvement in ultrasound inflammation at week 8 as compared to baseline, based on EULAR-OMERACT ultrasound scoring system.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- Shu Bi Ning (modified Si Miao Xiao Bi), Methotrexate, Shu Bi Ning placebo
- Keywords
- Rheumatoid Arthritis, Chinese Herbal Medicine, Traditional Chinese Medicine, Si Miao Xiao Bi
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shu Bi Ning (modified Si Miao Xiao Bi)Other
Shu Bi Ning (modified Si Miao Xiao Bi) is a chinese herbal medication for treatment of damp-heat syndrome.
MethotrexateDrug
Patients receive standard dose of oral methotrexate that is ordered by their attending rheumatologist.
Shu Bi Ning placeboOther
Placebo granules will be manufactured with no new herbal components (all herbal content is HSA certified). Placebo granules will comprise of 5% of the herbal components (using Modified Si Miao Xiao Bi), 95% black bean powder and 0.05% denatonium benzoate will be added as a bitterant. This is to ensure that the placebo possesses similar taste and smell of the herbal components. The placebo will be colour adjusted to match actual herbal granules, and the packaging for the herbal and placebo granules will be done using the same packaging material to ensure both are similar in appearance.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In addition to usual rheumatological care, patients receive take Shu Bi Ning for a period of 12 weeks. Receives: Other: Shu Bi Ning (modified Si Miao Xiao Bi); Drug: Methotrexate |
| Placebo | Placebo comparator | In addition to usual rheumatological care, patients receive take a Shu Bi Ning placebo for a period of 12 weeks. Receives: Drug: Methotrexate; Other: Shu Bi Ning placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
American College of Rheumatology 20% improvement criteria (ACR20) at week 8
To achieve an ACR20 response, a patient with RA must demonstrate a 20% improvement in both tender and swollen joint counts, and 20% improvement in at least three of the following five criteria: patient's assessment of disease activity, physician's assessment of treatment response, patient's ability to perform daily activities based on Health Assessment Questionnaire-Disability Index (HAQ-DI), pain level, and serum inflammation markers.
Measured: Enrollment to week 8.
Secondary outcomes (7)
ACR20 response at week 12
To achieve an ACR20 response, a patient with RA must demonstrate a 20% improvement in both tender and swollen joint counts, and 20% improvement in at least three of the following five criteria: patient's assessment of disease activity, physician's assessment of treatment response, patient's ability to perform daily activities based on Health Assessment Questionnaire-Disability Index (HAQ-DI), pain level, and serum inflammation markers.
Measured: Enrollment to week 12.
ACR50 response at weeks 8 and 12
To achieve an ACR50 response, a patient with RA must demonstrate a 50% improvement in both tender and swollen joint counts, and 50% improvement in at least three of the following five criteria: patient's assessment of disease activity, physician's assessment of treatment response, patient's ability to perform daily activities based on Health Assessment Questionnaire-Disability Index (HAQ-DI), pain level, and serum inflammation markers.
Measured: Enrollment to week 8, 12.
ACR70 response at weeks 8 and 12
To achieve an ACR70 response, a patient with RA must demonstrate a 70% improvement in both tender and swollen joint counts, and 70% improvement in at least three of the following five criteria: patient's assessment of disease activity, physician's assessment of treatment response, patient's ability to perform daily activities based on Health Assessment Questionnaire-Disability Index (HAQ-DI), pain level, and serum inflammation markers.
Measured: Enrollment to week 8, 12.
28-joint disease activity score using ESR (DAS28-ESR) at weeks 8, 12.
The DAS28-ESR is a composite measure used to evaluate disease activity in RA. It incorporates four components: the tender joint count (TJC) and swollen joint count (SJC) out of 28 specified joints, the patient's global health assessment using a visual analog scale (VAS), and the erythrocyte sedimentation rate (ESR), which is a marker of inflammation. The score ranges from 0 to 9.4, with thresholds defining remission (<2.6), low disease activity (2.6-3.2), moderate disease activity (>3.2-5.1), and high disease activity (>5.1).
Measured: Enrollment to week 8, 12.
Impact of RA on disability as measured using the Health Assessment Questionnaire-Disability Index (HAQ-DI) at weeks 8, 12.
The HAQ-DI is a self-reported measure of functional status. It consists of 20 questions across eight categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and usual activities. Each item is scored on a scale from 0 (no difficulty) to 3 (unable to do). The overall HAQ-DI score, ranging from 0 to 3, is calculated by averaging the eight category scores, with higher scores indicating greater disability.
Measured: Enrollment to week 8, 12.
Quality of life as measured using the Medical Outcomes Study Short-Form (36-item) Health Survey (SF-36) at week 8, 12
The SF-36 measures health-related quality of life (HRQoL). It comprises 36 questions that assesses eight health domains: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. These domains can be further summarized into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The SF-36 uses a scoring system ranging from 0 to 100 for each domain, with higher scores indicating better health status.
Measured: Enrollment to week 8, 12.
Fatigue level as measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale at week 8, 12.
The FACIT-F is a 13-item measure designed to assess self-reported fatigue and its impact on daily activities and function. Scores range from 0 to 52, where higher scores indicate less fatigue.
Measured: Enrollment to week 8, 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start1 Jun 2026
- Primary completion31 May 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies 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
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Thong Chai Institute of Medical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627893
- Sponsor's protocol ID
- 2025/0161
- Acronym
- CHARMS
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary Herbal Approach to Rheumatoid Management Study (CHARMS)
- ClinicalTrials.gov ID
- NCT07627893
- Acronym / sponsor ID
- CHARMS / 2025/0161
- Conditions
- Rheumatoid Arthritis (RA)
- Keywords
- Rheumatoid Arthritis, Chinese Herbal Medicine, Traditional Chinese Medicine, Si Miao Xiao Bi
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Thong Chai Institute of Medical Research
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 4 Jun 2026 (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 disease characterised by symmetric, polyarticular pain and swelling, involving small joints of the hands and feet. RA can lead to irreversible joint damage without treatment, causing disability and impacting daily activities and work productivity. Some patients turn to Chinese Herbal Medication (CHM) for treatment. Since there is currently no well designed randomised controlled trial to support the 'real-world' use of Si Miao Xiao Bi Tang with anti-rheumatic drugs, such as methotrexate, the investigators are conducting a 12-week, randomised double-blinded placebo-controlled trial to determine the efficacy, safety and cost effectiveness of a modified Si Miao Xiao Bi Tang, a type of CHM, in the treatment of patients with active RA.
Detailed description
From the Traditional Chinese Medicine (TCM) perspective, RA is part of the Bi Syndrome. Si Miao Xiao Bi Tang is one of the formulas listed in the guidelines for treatment of Damp-Heat syndrome. Till date, few studies have explored use of CHM, in particular Si Miao Xiao Bi Tang, in treating RA. According to past systematic reviews of radnomised controlled trials performed on Chinese herbs in RA patients, most studies were of low methodological quality and small numbers, resulting in lack of generalizability. Studies looking into cost effectiveness are also lacking.
Proposed project is a randomised double-blind placebo-controlled trial to be conducted over a period of three years, anchored to the Consolidated Standards of Reporting Trials (CONSORT) guidelines and CONSORT extension for CHM. Eligible patients will be randomly allocated to receive CHM and methotrexate or methotrexate and placebo on a 1:1 basis via random permuted block randomization.
Intervention group and control group patients receive methotrexate and CHM or methotrexate and placebo respectively for 12 weeks. They will attend rheumatologist reviews at weeks 0, 4, 8, and 12, including physical exams and disease monitoring. Safety is tracked through blood tests, and further tests are ordered as needed. TCM physicians participate by counselling and diagnosing TCM syndrome and monitoring for side effects during study visits at weeks 0, 4, 8 and 12.
American College of Rheumatology 20% improvement criteria (ACR20) at week 8 is the primary outcome. To achieve an ACR20 response, a patient with RA must demonstrate a 20% improvement in both tender and swollen joint counts, and 20% improvement in at least three of the following five criteria: patient's assessment of disease activity, physician's assessment of treatment response, patient's ability to perform daily activities based on Health Assessment Questionnaire-Disability Index (HAQ-DI), pain level, and serum inflammation markers.
Secondary outcomes include ACR20 response ACR50 response, ACR70 response, 28-joint disease activity score using ESR (DAS28-ESR), impact of RA on disability as measured using the Health Assessment Questionnaire Disability Index (HAQ-DI), severity of synovitis as determined using the EULAR-OMERACT ultrasound scoring system, quality of life as measured using the Medical Outcomes Study Short-Form (36-item) Health Survey (SF-36), fatigue level as measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale and safety of the trial.
Exploratory outcome is improvement in ultrasound inflammation at week 8 as compared to baseline, based on EULAR-OMERACT ultrasound scoring system.
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 |
|---|---|---|
| Intervention | Experimental | Other: Shu Bi Ning (modified Si Miao Xiao Bi), Drug: MethotrexateIn addition to usual rheumatological care, patients receive take Shu Bi Ning for a period of 12 weeks. |
| Placebo | Placebo comparator | Drug: Methotrexate, Other: Shu Bi Ning placeboIn addition to usual rheumatological care, patients receive take a Shu Bi Ning placebo for a period of 12 weeks. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients between the ages of 21 and 70 years, and diagnosed with RA by a rheumatologist and fulfilling the 2010 ACR/EULAR classification criteria for RA.
- Active disease with DAS28 ESR ≥3.2 at screening, with at least 6 swollen joints out of 66 and at least 6 tender joints out of 68.
- Receiving stable doses of methotrexate therapy for at least 3 months, and on stable dose for at least 4 weeks before trial entry ( ≥10mg per week), either subcutaneous or orally.
- Stable doses of non-steroidal anti-inflammatory drugs (NSAIDS), acetaminophen, or oral corticosteroids (equivalent to prednisone ≤ 10 mg) for at least 4 weeks prior to first dose of study medication.
- Except for methotrexate, patients must have discontinued all csDMARDs, including, but not limited to: hydroxychloroquine, sulfasalazine, leflunomide prior to first dose of study medication as specified below:
Key exclusion criteria (22 listed)
- Not able to provide informed consent.
- Previous lack of efficacy to Si Miao Xiao Bi Tang.
- History of inflammatory joint disease other than RA. Secondary Sjogren's Syndrome is permitted.
- Concurrent use of other immunosuppressant medications, except MTX and protocol allowed doses of steroids.
- Has been treated with intra-articular, intramuscular, intravenous, trigger point or tender point administration of corticosteroids in the preceding 4 weeks prior to the Baseline Visit.
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 |
|---|---|---|
| Shu Bi Ning (modified Si Miao Xiao Bi)Shu Bi Ning (modified Si Miao Xiao Bi) is a chinese herbal medication for treatment of damp-heat syndrome. | Other | Intervention |
| MethotrexatePatients receive standard dose of oral methotrexate that is ordered by their attending rheumatologist. | Drug | Intervention, Placebo |
| Shu Bi Ning placeboPlacebo granules will be manufactured with no new herbal components (all herbal content is HSA certified). Placebo granules will comprise of 5% of the herbal components (using Modified Si Miao Xiao Bi), 95% black bean powder and 0.05% denatonium benzoate will be added as a bitterant. This is to ensure that the placebo possesses similar taste and smell of the herbal components. The placebo will be colour adjusted to match actual herbal granules, and the packaging for the herbal and placebo granules will be done using the same packaging material to ensure both are similar in appearance. | Other | Placebo |
Primary outcome
American College of Rheumatology 20% improvement criteria (ACR20) at week 8
Time frame: Enrollment to week 8.
To achieve an ACR20 response, a patient with RA must demonstrate a 20% improvement in both tender and swollen joint counts, and 20% improvement in at least three of the following five criteria: patient's assessment of disease activity, physician's assessment of treatment response, patient's ability to perform daily activities based on Health Assessment Questionnaire-Disability Index (HAQ-DI), pain level, and serum inflammation markers.
7 secondary outcomes
ACR20 response at week 12
Time frame: Enrollment to week 12.
ACR50 response at weeks 8 and 12
Time frame: Enrollment to week 8, 12.
ACR70 response at weeks 8 and 12
Time frame: Enrollment to week 8, 12.
28-joint disease activity score using ESR (DAS28-ESR) at weeks 8, 12.
Time frame: Enrollment to week 8, 12.
Impact of RA on disability as measured using the Health Assessment Questionnaire-Disability Index (HAQ-DI) at weeks 8, 12.
Time frame: Enrollment to week 8, 12.
Quality of life as measured using the Medical Outcomes Study Short-Form (36-item) Health Survey (SF-36) at week 8, 12
Time frame: Enrollment to week 8, 12.
Fatigue level as measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale at week 8, 12.
Time frame: Enrollment to week 8, 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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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.
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 Shu Bi Ning (modified Si Miao Xiao Bi) and Methotrexate in people with Rheumatoid Arthritis (RA), run by Singapore General Hospital at 1 site in Singapore.
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 9 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. 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 Singapore. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Warren Fong (+65 63214028, warren.fong.w.s@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American College of Rheumatology 20% improvement criteria (ACR20) at week 8 (time frame: Enrollment to week 8.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.