NCT05540938RecruitingPhase 4
Post-marketing Re-evaluation of 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
Source: ClinicalTrials.gov · Last updated 20 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- First submitted
- 10 Sept 2022
- Start date
- 23 May 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- China-Japan Friendship Hospital
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05540938
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 340
- From 23 May 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- 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.).
Lab values
- 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.
Age
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.