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A clinical study on the treatment of refractory rheumatoid arthritis in combination with single Chinese medicine

A clinical study on the treatment of refractory rheumatoid arthritis in combination with single Chinese medicine

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052492
Enrollment
Unknown
Registered
2021-10-29
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Rheumatoid Arthritis

Interventions

Group 1:On the basis of traditional DMARD treatment, add traditional Chinese medicine Danshen tablets
Group 2:On the basis of traditional DMARD treatment, add traditional Chinese medicine Matrine tablets
Group 3:Add traditional Chinese medicine compound glycyrrhizin tablets on the basis of traditional DMARD treatment
Group 4:The traditional Chinese medicine aconitine injection is added to the traditional DMARD treatment

Sponsors

The Second Affiliated Hospital of Guangxi Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the 1987 American Rheumatology Association diagnostic criteria for RA: (1) Morning stiffness, not less than 60 minutes, for 6 weeks; (2) Arthritis in three or more joint areas for 6 weeks; (3) Arthritis of the hand joint: arthritis in at least one area of ??the wrist joint, MCP or PIP for 6 weeks; (4) Symmetric arthritis lasts for 6 weeks; (5) Rheumatoid nodules; (6) If the blood RF is positive, the method must ensure that the positive rate of the normal control population is not more than 5%; (7) Post-anterior radiographs of the hand and wrist joints show typical RA imaging changes, such as bone destruction, clear; (8) Osteoporosis around the affected joints. RA can be diagnosed when 4 or more of the criteria are met and other causes of arthritis are excluded; 2. Or meet the new RA classification criteria jointly proposed by EULAR and ACR in 2010: (1) Target group: 1) Synovitis (swelling) in at least one joint; 2) Synovitis is not caused by other diseases; A cumulative score of >= 6 in the criteria can be diagnosed as RA; (2) Affected joints: 0 points for 1 medium and large joints; 1 point for 2-10 medium and large joints; 2 points for 1-3 small joints; 3 points for 4-10 small joints; >10 ( At least 1 is a small joint) for 5 points; (3) Serology: 0 points for both RF or ACPA negative; 2 points for RF or ACPA at least one low titer positive; 3 points for RF or ACPA high titer positive; (4) Duration of synovitis: 0 points for 6 weeks; (5) Acute phase reactants: 0 points for normal CRP or ESR; 1 point for increased CRP or ESR; 3. No other organic diseases and no obvious symptoms of infection; 4. For unconscious disorder, communication disorder, and intellectual disability, the staff can be assigned to complete questionnaires such as depression scale, SF-36 questionnaire, and VAS score; 5. Age 18-80 years old; 6. At the same time diagnosed with refractory rheumatoid arthritis (disease duration >= 24 months, using at least 2 anti-rheumatic drugs for > 3 months with poor effect, disease activity DAS28 score > 3.2 points).

Exclusion criteria

Exclusion criteria: Allergic to traditional Chinese medicine ingredients; or a history of active tuberculosis; malignant tumor; moderate to severe heart failure (New York Heart Association grade 3-4); pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
Morning stiffness time;Joint swelling and tenderness;His hands grip strength;VAS pain index;Evaluation of patients with rheumatoid arthritis (DAS28 score);Crohn's disease disease activity index (CDAI) score;Rheumatoid Arthritis SDAI Score;Lung function;

Countries

China

Contacts

Public ContactLi Meiling

The Second Affiliated Hospital of Guangxi Medical University

2189356143@qq.com+86 18260948598

Outcome results

None listed

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