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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02264301
• Other study ID #: QKL20140588
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 3, 2014
• Last updated: March 31, 2017
• Start date: August 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2017
• Source: Chengdu PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Puerarin injection 400 mg

• Qingkailing injection 40 ml

Locations

Country	Name	City	State
China	General Hospital of Chengdu Military Area Command PLA	Chengdu

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 • v(tender joint count) + 0.28 •v(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