Qingkailing Injection Versus Puerarin Injection on Withdrawal Rate of Corticosteroids in Patients With Active Rheumatoid Arthritis

Study Overview
=================
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.

Official Title
-----------------
The Effect of Qingkailing Injection on Corticosteroids Withdrawal Rate in Patients With Active Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Puerarin injection 400 mg
* Drug: Qingkailing injection 40 ml


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Puerarin injection 400 mg<br>Patients under the treatment of Puerarin injection 400 mg,daily,for 24 weeks | Drug: Puerarin injection 400 mg<br> <br> |
| Experimental: Qingkailing injection 40 ml<br>Patients under the treatment of Qingkailing injection 40 ml,daily,for 24 weeks | Drug: Qingkailing injection 40 ml<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in corticosteroids withdrawal rate at 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. | At 0 week, 12 weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Disease activity score in 28 joints(DAS28) | 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 | At 0 week, 12 weeks, 24 weeks |