Tests WangBi granules with standard drugs in rheumatoid arthritis patients
Tests WangBi granules added to usual treatment in adults with low-activity rheumatoid arthritis.
Plain-language title generated from the registry record
Registry title: Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05540938, who can take part
Where in China
- China-Japan Friendship HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- China-Japan Friendship Hospital
- Trial code
- NCT05540938
- Record updated
- 20 January 2025
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Age 18-75 years; Meeting the 1987 ACR or 2010 ACR/EULAR diagnostic criteria; Meeting the diagnostic criteria of Chinese medicine for Kidney deficiency and dampness and stasis blocking channels in Chinese medicine; Rheumatoid arthritis disease activity score DAS28 of 2.6 to 3.2; Regularly taking methotrexate 7.5-15 mg qw and tofacitab 5 mg bid before enrollment and stable treatment regimen for more than 4 weeks; Voluntary participation and signed written informed consent.
Exclusion: 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); 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; Persons with a BMI greater than 35 (kg/m2), allergic to the test drug, or participating in other clinical trials; Other conditions deemed by the investigator to be inappropriate for trial participation (out-of-town patients unable to be followed up, etc.); 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; 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.