NCT05540938 Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis
| NCT ID | NCT05540938 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | China-Japan Friendship Hospital |
| Condition | Rheumatoid Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 340 participants |
| Start Date | 2023-05-23 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 340 participants in total. It began in 2023-05-23 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The group used a randomized controlled trial to conduct a post-marketing re-evaluation study of Wangbi granules. The study was conducted to observe the degree of clinical remission in rheumatoid arthritis patients with low disease activity after standard methotrexate and tofacitinib citrate treatment, using a combination of Chinese and Western medicine treatment with Wangbi granules. The study aims to provide evidence-based medical evidence to improve the clinical efficacy of rheumatoid arthritis, enhance the depth of remission, and improve the diagnosis and treatment of rheumatoid arthritis.
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.).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05540938 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Rheumatoid Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05540938 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05540938 currently recruiting?
Yes, NCT05540938 is actively recruiting participants. Contact the research team at wzhbucm@163.com for enrollment information.
Where is the NCT05540938 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05540938 clinical trial?
NCT05540938 is sponsored by China-Japan Friendship Hospital. The trial plans to enroll 340 participants.
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