Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this study is to evaluate the effect of Qingkailing injection versus Puerarin injection on withdrawal rate of corticosteroids in patients with active rheumatoid arthritis.
Interventions
DRUGQingkailing injection 40 ml
Sponsors
Chengdu PLA General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* with active RA * without taking any other medication for the treatment of active RA in at least 4 last weeks * aged from 18 to 75 years * without conflict to the written, informed consent signed prior to the enrollment.
Exclusion criteria
* being included in other clinical trial within the last 4 weeks * with abnormal liver or kidney function (more than 1 time above the high normal) * with serious cardiovascular disease * with hematologic disease * being in pregnancy, lactation period or under a pregnancy plan * with severe gastrointestinal disease * with contraindication or being allergic to the test drugs * being under the treatment of drugs within 1 previous week, that might affect the results of the trial, such as non-steroidal anti-inflammatory drugs, steroidal anti-inflammatory drugs, immunosuppressants, anti-ulcer drugs * being not compatible for the trial medication, or other circumstances at the discretion of investigators * without legal capacity or only with limited legal capacity.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in corticosteroids withdrawal rate at 24 weeks | At 0 week, 12 weeks, 24 weeks | The number (rate) of patients who do not need the use of corticosteroids any more were monitored 0 week, 12 weeks, 24 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Disease activity score in 28 joints(DAS28) | At 0 week, 12 weeks, 24 weeks | Disease activity of RA is assessed using disease activity score in 28 joints (DAS28). DAS28 = 0.56 • √(tender joint count) + 0.28 •√(swollen joint count) + 0.70 In(ESR) + 0.014(global health on visual analogue scale).DAS28 will be assessed at At 0 week, 12 weeks and 24 weeks |
Countries
China
Outcome results
None listed