Multicentered Clinical Evaluation Studies on Treating Active Rheumatoid Arthritis by the Method of Clearing Heat and Promoting Blood Flow

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-09000377

Enrollment

Unknown

Registered

2009-04-16

Start date

2007-07-01

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 of MTX:Methotrexate Tablets: 10mg 1/w

Group of Both MTX and Herbs:The Formula of Clearing Away Damp-heat and Promoting Blood Flow: 200ml bid

Methotrexate Tablets: 10mg 1/w

Group of Herbs:The Formula of Clearing Away Damp-heat and Promoting Blood Flow: 200ml bid

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: The patients 1. who meets 1987 ACR criteria for rheumatoid arthritis (RA) and the diagnostic criteria for the TCM syndrome of obstruction of channels by damp-heat and blood stasis; and 2. with the age in the range from 18 to 65; and 3. with the joint function in the range from Grade I to Grade III; and 4. with the X-ray in the range from Stage I to Stage III; and 5. whose disease is in an active stage; and the definition of the active stage is to meet three items as below simultaneously: (1) swelling joint>=3; (2) tender joint>=6; (3) morning stiffness>=30min; (4) erythrocyte sedimentation rate (ESR)>=28mm/h or C-reaction protein (CRP) 20% higher than normal value; and 6. who has signed on the informed consent.

Exclusion criteria

Exclusion criteria: The patients 1. who does not meet 1987 ACR criteria for RA or the diagnostic criteria for the TCM syndrome; or 2. with the joint function in Grade IV; or 3. who is less than 18 or more than 65 years old, pregnancy, or in lactation; or 4. who has severe primary diseases of cardiovascular, liver, kidney, or hematopoietic system, etc., or mental disorders; or 5. who has not stopped using the glucocorticoids, the other immunosuppressive agents, such as the chloroquine, the sulfasalazine, the cyclophosphamide, or the penicillamine, etc., or the other Chinese herbal products treating RA at least one month before this study.

Design outcomes

Primary

Measure	Time frame
criteria for therapeutic effects;Evaluation of the therapeutic effect on TCM syndrom;	—

Secondary

Measure	Time frame
Sharp Score for joint radiology;Evaluation of quality of life in patients;	—

Countries

China

Contacts

Public ContactJiang Quan, Feng Xinghua

doctorjiangquan@yahoo.com.cn+86 0 13901081632

Outcome results

None listed

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