Clinical trial NCT05540938: Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College Hospital
name: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
name: The 980th Hospital of PLA Joint Logistics Support Force
name: The Second Affiliated Hospital of Zhejiang Chinese Medical University
name: Southwest Hospital, China
First posted: 2022-09-15
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.).

Primary outcomes:
measure: DAS28
timeFrame: 12 weeks
Secondary outcomes:
measure: Fatigue Scale-14
timeFrame: 12 weeks
measure: visual analogue scale
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: China-Japan Friendship Hospital
Study officials:
References: