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

Chengdu PLA General Hospital150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Rheumatoid Arthritis

Interventions

Puerarin injection 400 mgDRUG

Qingkailing injection 40 mlDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

General Hospital of Chengdu Military Area Command PLA

Chengdu, China

Outcomes

Primary Outcomes

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.

Time frame: At 0 week, 12 weeks, 24 weeks

Secondary Outcomes

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

Time frame: At 0 week, 12 weeks, 24 weeks

Data from ClinicalTrials.gov

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