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Study on the clinical efficacy and mechanism of treating rheumatoid arthritis based on the theory of "dampness and heat and toxic stasis" and metabolomics technique

Study on the clinical efficacy and mechanism of treating rheumatoid arthritis based on the theory of "dampness and heat and toxic stasis" and metabolomics technique

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076847
Enrollment
Unknown
Registered
2023-10-22
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatoid arthritis

Interventions

Test group:Gentiana reussia Tongbi soup+MTX
Healthy control group:NA

Sponsors

Jiangsu Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1 Patients who met the diagnostic criteria for RA in rheumatoid arthritis 2. Patients with acute onset within 2 weeks who meet the criteria for RA activity 3. Patients who meet the criteria of RA dampness and heat toxicity syndrome 4. Age is 18-60 years old, male or female 5. Patients enrolled in this study should have previously undiagnosed rheumatoid arthritis and have not received relevant antirheumatic drugs within 3 months prior to disease onset 6. All patients and their families were aware of the study purpose, study method and the risks of participating in the study, volunteered to participate in the study,signed relevant informed consent, and were approved by the Ethics Committee of the Affiliated Hospital of Nanjing University of Traditional Chinese Medicine

Exclusion criteria

Exclusion criteria: 1. Patients with seronegative rheumatic immune diseases and other rheumatic immune diseases such as spinal arthropathy, dermatomyositis, systemic lupus erythematosus, gouty arthritis, Sjogren's syndrome, psoriatic arthritis and scleroderma 2. Patients with severe extraarticular manifestations of rheumatoid arthritis during the onset of the disease 3. Patients with acute or chronic infectious diseases, especially those with septic arthritis 4. Patients with active TB or suspected TB 5. Patients allergic to methotrexate drugs 6. Patients allergic or intolerant to Chinese medicine decoction 7. Pregnant or lactating women who have birth planning within 3 months of the trial or the end of the trial 8. Patients with severe cardiovascular and cerebrovascular diseases such as hypertension, coronary heart disease, cerebral infarction and congestive heart failure; liver and kidney insufficiency andgastrointestinal diseases, especially gastrointestinal ulcer and hematopoietic diseases; patients with malignant tumors 9. Patients with chickenpox 10. Patients with mental system diseases, cognitive dysfunction, consciousness disorders, and inability to communicate effectively 11. Patients with congenital joint deformity, previous fracture trauma of large joint, joint replacement and other surgical treatment

Design outcomes

Primary

MeasureTime frame
metabonomics ;Disease efficacy evaluation;DAS28 rating;Quantitative classification of traditional Chinese medicine syndromes;

Secondary

MeasureTime frame
Rheumatoid factor;anti-ring citrullinine antibody;blood sedimentation;C reactive protein ;

Countries

China

Contacts

Public ContactLU LU

Jiangsu Provincial Hospital of Traditional Chinese Medicine

lulu1986_16@163.com+86 139 1599 2820

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026