Qingkailing Injection Versus Puerarin Injection on Withdrawal Rate of Corticosteroids in Patients With Active Rheumatoid Arthritis
The Effect of Qingkailing Injection on Corticosteroids Withdrawal Rate in Patients With Active Rheumatoid Arthritis
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable rheumatoid-arthritis
Started Aug 2014
Typical duration for not_applicable rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 3, 2014
CompletedFirst Posted
Study publicly available on registry
October 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedApril 4, 2017
March 1, 2017
3.3 years
October 3, 2014
March 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Change from baseline in Disease activity score in 28 joints(DAS28)
At 0 week, 12 weeks, 24 weeks
Study Arms (2)
Puerarin injection 400 mg
ACTIVE COMPARATORPatients under the treatment of Puerarin injection 400 mg,daily,for 24 weeks
Qingkailing injection 40 ml
EXPERIMENTALPatients under the treatment of Qingkailing injection 40 ml,daily,for 24 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General Hospital of Chengdu Military Area Command PLA
Chengdu, 610083, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D
Study Record Dates
First Submitted
October 3, 2014
First Posted
October 15, 2014
Study Start
August 1, 2014
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
April 4, 2017
Record last verified: 2017-03