Can a traditional chinese herb tame stubborn rheumatoid arthritis?

NCT ID NCT07721142

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time

Summary

This trial investigates whether adding Kunxian Capsule, a traditional Chinese herbal remedy, to standard medications (methotrexate and tofacitinib) can improve outcomes for people with refractory rheumatoid arthritis — a form that does not respond well to usual treatments. About 300 adults aged 50 to 70 with this condition will receive either the herbal capsule or a placebo for 12 weeks. The main goal is to see if more patients achieve at least a 20% improvement in arthritis symptoms (ACR20) by the end of the study.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Kunxian Capsule (a traditional Chinese herbal medicine) combined with methotrexate and tofacitinib
What this could lead to
If effective, this combination could offer a new option for people with rheumatoid arthritis that does not respond well to standard treatments.
What could go wrong
This is a phase 4 trial, so the intervention is already in use, but its specific benefit over placebo in this combination is unproven. Herbal medicines can have side effects and interactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria Subjects must meet all of the following criteria to be enrolled in this study: 1. Fully understand the purpose and requirements of the trial, voluntarily participate by signing written informed consent, and be willing and able to complete the study procedures, including medication administration and follow-up assessments; 2. Male patients aged ≥50 years with no fertility requirements, or postmenopausal female patients, younger than 70 years; 3. Patients diagnosed with rheumatoid arthritis (RA) according to the 1987 revised criteria of the American College of Rheumatology (ACR), or the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria; 4. Patients with RA of the "Wind-Damp Bi obstruction" pattern according to traditional Chinese medicine (TCM), defined as: * Primary symptoms: joint pain and swelling with a wandering nature; joint pain and swelling with intermittent occurrence. * Secondary symptoms: aversion to wind, or spontaneous sweating; headache; heaviness of the limbs. Tongue and pulse: pale-red tongue with thin white coating, slippery or floating pulse.Diagnosis requires at least 2 primary symptoms, or 1 primary symptom plus 2 secondary symptoms, in combination with tongue and pulse findings. 5. Patients with confirmed moderate to severe active RA at screening, defined as ≥6 tender joints (TJC, based on 68-joint count) and ≥6 swollen joints (SJC, based on 66-joint count), with erythrocyte sedimentation rate (ESR) \>28 mm/h or C-reactive protein (CRP) \>10 mg/L, and DAS28-CRP \>3.2; 6. Prior inadequate response (DAS28-ESR \>3.2) to at least two disease-modifying antirheumatic drug (DMARD) regimens (excluding methotrexate + JAK inhibitor + Kunxian capsule), each administered for at least 12 weeks. Exclusion Criteria Subjects meeting any of the following conditions will not be eligible for enrollment: 1. Suspected or confirmed allergy to the investigational drug (including excipients or drugs of the same class), or any other severe allergic disease (excluding RA itself) that, in the investigator's judgment, may compromise subject safety; 2. Presence of inflammatory diseases other than RA, including but not limited to psoriatic arthritis, ankylosing spondylitis, or systemic lupus erythematosus; 3. Severe, progressive, or uncontrolled diseases of the kidneys, liver, blood, gastrointestinal tract, endocrine system, lungs, heart, nervous system, psychiatric conditions, or brain; history of venous thromboembolism, diverticulitis, significantly abnormal or poorly controlled blood lipids; 4. History of lymphoproliferative disorders, or current or past malignancy; 5. Meeting any of the following criteria for tuberculosis screening, which require exclusion: * History of active tuberculosis; * Recent close contact with patients with active tuberculosis; * Signs or symptoms of active tuberculosis based on medical history and physical examination; * Chest CT scan within 3 months prior to enrollment showing evidence of active pulmonary tuberculosis; * Positive interferon-gamma release assay (IGRA) within 6 weeks prior to enrollment; 6. Presence or history of active infections, including: * Receipt of systemic anti-infective therapy within 4 weeks prior to randomization; * Pharyngalgia, nasal congestion, acute upper respiratory tract infection, or systemic acute infection within 2 weeks prior to randomization; * Recurrent, chronic, or other active infections at screening that, in the investigator's judgment, may increase subject risk; 7. History of recurrent herpes zoster, disseminated herpes zoster, or disseminated herpes simplex, or history of herpes zoster or herpes simplex within 2 months prior to randomization; 8. Positive hepatitis B surface antigen (HBsAg) and/or HBV DNA \>50 IU/mL (or \>500 copies/mL) at screening; positive hepatitis C virus antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody; 9. Receipt of, or planned receipt of, live or attenuated vaccines within 3 months prior to the first dose of study medication, during the study, or within 6 months after the last study dose; 10. Pregnant, breastfeeding, planning pregnancy, or planning fatherhood during the study or within 6 months after the last dose; females or males with fertility requirements; 11. Clinically significant abnormalities on 12-lead ECG at screening that may increase subject risk, in the investigator's judgment; 12. Any other disease at screening that may interfere with study assessments; 13. Laboratory abnormalities at screening, defined as: 1. Hemoglobin \<100.0 g/L in males, or \<90.0 g/L in females; 2. White blood cell (WBC) count \<4.0 × 10⁹/L; 3. Neutrophil count \<1.5 × 10⁹/L; 4. Platelet (PLT) count \<100 × 10⁹/L; 5. Lymphocyte count \<0.5 × 10⁹/L; 6. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (TBIL), or serum creatinine (Scr) above the upper limit of normal; 7. Hematology, liver function, or renal function abnormalities that, in combination with medical history and/or additional examinations, are deemed clinically significant by the investigator; 14. Prior use of any of the following drugs or treatments: 1. Strong opioids within 1 week prior to randomization; 2. Any JAK inhibitor within 2 weeks prior to randomization; 3. Nonsteroidal anti-inflammatory drugs (NSAIDs) at the time of randomization with dosage adjustments within 2 weeks prior; 4. Prednisone or equivalent corticosteroid \>10 mg/day at randomization; or ≤10 mg/day with dosage adjustment within 4 weeks prior to randomization; 5. Intra-articular, intramuscular, intravenous, trigger-point, bursal, or tendon-sheath corticosteroid injections within 4 weeks prior to randomization or during the study; 15. Concurrent participation in another drug clinical trial; 16. Any clinically significant abnormalities in clinical or laboratory examinations, or any other reason deemed inappropriate for study participation by the investigator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Guanghua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

    RECRUITING

    Shanghai, China

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