Actively Recruiting
Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis
Led by China-Japan Friendship Hospital · Updated on 2025-01-20
340
Participants Needed
1
Research Sites
149 weeks
Total Duration
On this page
Sponsors
C
China-Japan Friendship Hospital
Lead Sponsor
P
Peking Union Medical College Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years
- Diagnosed with rheumatoid arthritis according to the 1987 ACR or 2010 ACR/EULAR criteria
- Meets Chinese medicine diagnostic criteria for Kidney deficiency and dampness and stasis blocking channels
- Rheumatoid arthritis disease activity score (DAS28) between 2.6 and 3.2
- Taking methotrexate 7.5-15 mg weekly and tofacitinib 5 mg twice daily with a stable regimen for more than 4 weeks
- Voluntary participation with signed informed consent
You will not qualify if you...
- Use of immunosuppressive drugs other than traditional DMARDs within 3 months before enrollment
- History of organ transplant or malignant tumors
- Impaired heart, brain, liver (ALT/AST > 3 times normal), kidney (creatinine clearance <60 ml/min), or other important organ function impairment
- Psychiatric or neurological disorders including cognitive disorders, depression, anxiety, cerebral infarction, hemorrhage, epilepsy, TIA, myelitis, demyelinating lesions, restless legs syndrome, or peripheral neurological disorders
- Pregnant or breastfeeding women, or those planning pregnancy within 6 months
- Women of childbearing age unable or unwilling to use adequate contraception or whose partner is unwilling during the study and up to 1 month after last dose
- Body mass index (BMI) over 35 kg/m2
- Allergy to the study drug
- Participation in other clinical trials
- Other conditions deemed unsuitable by the investigator, including inability to comply with follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, China, 100029
Actively Recruiting
Research Team
Z
Zihan Wang, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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