Evaluating WangBi Granules for Rheumatoid Arthritis

Reevaluation of Original Research Results of Integrated Traditional Chinese and Western Medicine and Transformation of Hospital Preparations: Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis

This study is testing if WangBi granules can help people with rheumatoid arthritis who are already on standard treatments feel better and achieve remission.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 340 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: China-Japan Friendship Hospital (Academic / other)
• Drugs / interventions: methotrexate, tofacitinib
• Locations: 1 site (Beijing)
• Trial ID: NCT05540938 on ClinicalTrials.gov

What this trial studies

This study conducts a randomized controlled trial to re-evaluate the effectiveness of WangBi granules in patients with rheumatoid arthritis who have low disease activity after standard treatments with methotrexate and tofacitinib citrate. The approach combines traditional Chinese medicine with Western medicine to assess clinical remission rates. The goal is to provide evidence-based insights that could enhance treatment outcomes and improve the management of rheumatoid arthritis.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with rheumatoid arthritis meeting specific diagnostic criteria and currently on stable methotrexate and tofacitinib treatments.

Not a fit: Patients who have recently taken immunosuppressive drugs or have serious comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and better management of rheumatoid arthritis for patients.

How similar studies have performed: Other studies have explored the integration of traditional Chinese medicine with Western treatments, showing promising results, but this specific approach with WangBi granules is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Age 18-75 years.
2. Meeting the 1987 ACR or 2010 ACR/EULAR diagnostic criteria.
3. Meeting the diagnostic criteria of Chinese medicine for Kidney deficiency and dampness and stasis blocking channels in Chinese medicine.
4. Rheumatoid arthritis disease activity score DAS28 of 2.6 to 3.2.
5. Regularly taking methotrexate 7.5-15 mg qw and tofacitab 5 mg bid before enrollment and stable treatment regimen for more than 4 weeks.
6. Voluntary participation and signed written informed consent.

Exclusion Criteria:

1. Patients taking immunosuppressive drugs other than traditional DMARDs for rheumatoid arthritis within 3 months prior to enrollment (traditional DMARDs include hydroxychloroquine sulfate, methotrexate, salazosulfapyridine tablets, and raglan polysaccharide tablets, among others).
2. Organ transplant recipients, patients with malignant tumors, patients with heart, brain, liver (ALT/AST \> 3 times the normal upper limit), kidney (Ccr \<60ml/min) and other important organ function impairment or hematological system diseases.
3. Psychiatric disorders such as cognitive disorders, depression, anxiety disorders, somatic dysfunction, cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating lesions and other central neurological disorders, or peripheral neurological disorders such as restless legs syndrome. peripheral neurological disorders such as restless legs syndrome.
4. Women and men who are pregnant or breastfeeding or who are planning a pregnancy within the next 6 months; during the trial or within 1 month of the last dose Women of childbearing age who are unable or unwilling to use adequate contraception, or whose spouse is unwilling to use contraception, within one month of the last dose or within one month of the last dose are unwilling to use contraception.
5. Persons with a BMI greater than 35 (kg/m2), allergic to the test drug, or participating in other clinical trials.
6. Other conditions deemed by the investigator to be inappropriate for trial participation (out-of-town patients unable to be followed up, etc.).

Where this trial is running

Beijing

• China-Japan Friendship Hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Zihan Wang, Dr

Conditions Rheumatoid Arthritis