Rheumatoid Arthritis
Conditions
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.
Interventions
DRUGWangbi granules
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months.
DRUGWangbi granules simulant
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months.
Sponsors
Peking Union Medical College Hospital
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
The 980th Hospital of PLA Joint Logistics Support Force
The Second Affiliated Hospital of Zhejiang Chinese Medical University
Southwest Hospital, China
China-Japan Friendship Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DAS28 | 12 weeks | Disease mobility score for 28 joints, higher scores indicate higher disease activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Scale-14 | 12 weeks | assessing the patient's fatigue level, the higher the score, the more severe the fatigue |
| visual analogue scale | 12 weeks | Patients score according to the level of pain they feel, there are 10 scales from 0-10, with 0 representing no pain and 10 representing severe pain |
Countries
China
Contacts
Primary ContactZihan Wang, Dr
Outcome results
None listed