Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis
NCT ID: NCT05540938
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
340 participants
INTERVENTIONAL
2023-05-23
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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treatment group
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months.
Wangbi granules
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months.
control group
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months.
Wangbi granules simulant
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months.
Interventions
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Wangbi granules
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months.
Wangbi granules simulant
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months.
Eligibility Criteria
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Inclusion Criteria
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
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.).
18 Years
75 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
OTHER
The 980th Hospital of PLA Joint Logistics Support Force
UNKNOWN
The Second Affiliated Hospital of Zhejiang Chinese Medical University
OTHER
Southwest Hospital, China
OTHER
China-Japan Friendship Hospital
OTHER
Responsible Party
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Zihan Wang
Principal Investigator
Locations
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China-Japan Friendship Hospital
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Zihan Wang
Role: primary
References
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Wang J, Wang Z, Lan T, Zhang L, Li Z, Wang X, Zou Q, Wang Y, Li Y, Luo R, Zhang N, Xu Y, Li M, Tao Q. Wangbi granule as a combination therapy to achieve clinical deep remission in rheumatoid arthritis: protocol for a multicenter, triple-blind, randomised, placebo-controlled trial. Chin Med. 2023 Feb 28;18(1):22. doi: 10.1186/s13020-023-00728-6.
Other Identifiers
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2022-NHLHCRF-LX-02-02
Identifier Type: -
Identifier Source: org_study_id
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