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

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ClinicalTrials.gov Identifier: NCT02264301
Recruitment Status : Unknown
Verified March 2017 by Yang Min, Chengdu PLA General Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : October 15, 2014
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
Yang Min, Chengdu PLA General Hospital

Tracking Information
First Submitted Date  ICMJE October 3, 2014
First Posted Date  ICMJE October 15, 2014
Last Update Posted Date April 4, 2017
Study Start Date  ICMJE August 2014
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 14, 2014)
Change from baseline in corticosteroids withdrawal rate at 24 weeks [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2014)
Change from baseline in Disease activity score in 28 joints(DAS28) [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Qingkailing Injection Versus Puerarin Injection on Withdrawal Rate of Corticosteroids in Patients With Active Rheumatoid Arthritis
Official Title  ICMJE The Effect of Qingkailing Injection on Corticosteroids Withdrawal Rate in Patients With Active Rheumatoid Arthritis
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Puerarin injection 400 mg
  • Drug: Qingkailing injection 40 ml
Study Arms  ICMJE
  • Active Comparator: Puerarin injection 400 mg
    Patients under the treatment of Puerarin injection 400 mg,daily,for 24 weeks
    Intervention: Drug: Puerarin injection 400 mg
  • Experimental: Qingkailing injection 40 ml
    Patients under the treatment of Qingkailing injection 40 ml,daily,for 24 weeks
    Intervention: Drug: Qingkailing injection 40 ml
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 14, 2014)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02264301
Other Study ID Numbers  ICMJE QKL20140588
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Yang Min, Chengdu PLA General Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Chengdu PLA General Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chengdu PLA General Hospital
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP