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Effectiveness and safety of Chinese herbal medicine in low responders in patient population of rheumatoid arthritis under MTX-based conventional therapy

Effectiveness and safety of Chinese herbal medicine in low responders in patient population of rheumatoid arthritis under MTX-based conventional therapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13002981
Enrollment
Unknown
Registered
2013-01-07
Start date
2013-01-07
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

rheumatoid arthritis

Interventions

A:GTT tablets, 10 mg 3 times a day after meals. Yi Shen Juan Bi (YSJB) ,1 pocket (8 g) 3 times a day after meals
B:Methotrexate (MTX)10 mg/week and Sulfasalazine (SSZ),at an initial dose of 0.5 g three times a day in the first week, from the second week the dose was 1.0g twice a day

Sponsors

Institute of Basic Research in Clinical Medicine China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: The criteria for entry were an age of 18 to 70 years; class I, II, or III stage RA fulfilling the criteria of the American Rheumatism Association[38]; and active disease (Active RAwas defined by the presence of three or more swollen joints, six or more tender joints, morning stiffness that lasted at least 30 minutes, and at least one of the following: an erythrocyte sedimentation rate of at least 28 mm per hour, or an elevated serum C-reactive protein concentration of at least 20% higher than normal value).

Exclusion criteria

Exclusion criteria: Patients were not eligible for the study if they had other important concurrent illnesses; if they had stage IV disease [38] or were allergic to any of the study drugs; if they received other commercial or experimental biological therapies for RA,if they were women of childbearing age who were not usingcontraception. Disease-modifying antirheumatic drugsother than MTX and SSZ, including hydroxychloroquine,cyclophosphamide, oral corticosteroids (=10 mg prednisone or equivalent), were discontinued at least four weeks beforethe study began. Stable doses of nonsteroidal antiinflammatorydrugs were allowed.

Design outcomes

Primary

MeasureTime frame
rest pain;joint tenderness;joint swelling;morning stiffness;average hand strength;time for 20 meters walking;global assessment of disease activity by the patient;physician's global assessment of disease activity;ESR CRP RF;

Secondary

MeasureTime frame
HAQ;radiography;TCM symptoms questionaire;

Contacts

Public ContactAiping LU
lap64067611@126.com+86 13901375357

Outcome results

None listed

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