Qingkailing Injection Versus Puerarin Injection on Withdrawal Rate of Corticosteroids in Patients With Active Rheumatoid Arthritis
Not Applicable
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: Qingkailing injection 40 ml
- Registration Number
- NCT02264301
- Lead Sponsor
- Chengdu PLA General Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Puerarin injection 400 mg Puerarin injection 400 mg Patients under the treatment of Puerarin injection 400 mg,daily,for 24 weeks Qingkailing injection 40 ml Qingkailing injection 40 ml Patients under the treatment of Qingkailing injection 40 ml,daily,for 24 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
General Hospital of Chengdu Military Area Command PLA
🇨🇳Chengdu, China