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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Puerarin injection 400 mg Drug: Qingkailing injection 40 ml Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Qingkailing Injection on Corticosteroids Withdrawal Rate in Patients With Active Rheumatoid Arthritis
Study Start Date : August 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Puerarin injection 400 mg
Patients under the treatment of Puerarin injection 400 mg,daily,for 24 weeks
 Drug: Puerarin injection 400 mg
Experimental: Qingkailing injection 40 ml
Patients under the treatment of Qingkailing injection 40 ml,daily,for 24 weeks
 Drug: Qingkailing injection 40 ml


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02264301


Locations
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China
General Hospital of Chengdu Military Area Command PLA
Chengdu, China, 610083
Sponsors and Collaborators
Chengdu PLA General Hospital
More Information
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Responsible Party: Yang Min, Ph.D, Chengdu PLA General Hospital
ClinicalTrials.gov Identifier: NCT02264301    
Other Study ID Numbers: QKL20140588
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Puerarin
Vasodilator Agents