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Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Method of Activating Blood Circulation by Removing Blood Stasis

Randomized Controlled Study to Evaluate the Clinical Outcomes of Rheumatoid Arthritis Treated with Method of Activating Blood Circulation by Removing Blood Stasis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10001014
Enrollment
Unknown
Registered
2010-08-30
Start date
2010-09-01
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

Group A:observation group: Leflunomide Tablets, from the first day to the third day, 50mg, qd, po, then 20mg, qd, po. Ligustrazine Powder-Needle, 0.12g, solubling in 5% GS/NS 100ml, qd, iv, in 30 to 6
Group B:control group: Leflunomide Tablets, from the first day to the third day, 50mg, qd, po, then 20mg, qd, po.

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Be diagnosed with RA as defined by the 1987 America College of Rheumatology (ACR) criteria, and the disease progression is in the I, II, or III phase, in active phase; 2. Sign the informed consent by patient or guardian; 3. Platelet count>=100*10^9/L.

Exclusion criteria

Exclusion criteria: 1. To combine with severe diseases in cardiovascular, lung, liver, renal, hematopoietic systems, or have to apply glucocorticoids for hyperpyrexia, interstitial pneumonia, renal amyloidosis, constrictive pericardium, central nervous system vasculitis; 2. To take the following drugs for a long-term till 1 month before participating in this study: glucocorticoids, chloroquine, sulfasalazine, cyclophosphamide, penicillamine, gold preparations, anticancer agent, and Chinese medicine which has the similar efficacy for RA; 3. Being involved in other clinical trials at present or 1 month before participating in this study; 4. Researchers in this study; 5. Inaptitude for the clinical protocols, for example, being allergic to sulfanilamide; 6. Combine with gastrointestinal tract diseases in active phase, to have esophagus or enteron ulcers within 30 days before participating in this study (don't exclude patients with alimentary tract hemorrhage history long before); 7. Platelet count<100*10^9/L or with t hemorrhagic tendency, or thrombocytopenia history long before; h. women during pregnancy or lactation, or planning to get pregnant; 8. Men who want to generate; 9. Mental patients.

Design outcomes

Primary

MeasureTime frame
Rest pain, pressing pain on joints, arthrocele, early morning stiffness, average grip of both hands;

Secondary

MeasureTime frame
Laboratory examinations: ESR, RF, CRP, IgA, IgG, IgM, hemorheology, X-ray, Pattern information of Chinese Medicine;

Countries

China

Contacts

Public ContactAiping Lu
lap64067611@126.com+86 10 64014411-3301

Outcome results

None listed

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