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

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Puerarin injection 400 mg
Qingkailing injection 40 ml
Sponsored by
Chengdu PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • General Hospital of Chengdu Military Area Command PLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Puerarin injection 400 mg

Qingkailing injection 40 ml

Arm Description

Patients under the treatment of Puerarin injection 400 mg,daily,for 24 weeks

Patients under the treatment of Qingkailing injection 40 ml,daily,for 24 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 3, 2014
Last Updated
March 31, 2017
Sponsor
Chengdu PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02264301
Brief Title
Qingkailing Injection Versus Puerarin Injection on Withdrawal Rate of Corticosteroids in Patients With Active Rheumatoid Arthritis
Official Title
The Effect of Qingkailing Injection on Corticosteroids Withdrawal Rate in Patients With Active Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chengdu PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Puerarin injection 400 mg
Arm Type
Active Comparator
Arm Description
Patients under the treatment of Puerarin injection 400 mg,daily,for 24 weeks
Arm Title
Qingkailing injection 40 ml
Arm Type
Experimental
Arm Description
Patients under the treatment of Qingkailing injection 40 ml,daily,for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Puerarin injection 400 mg
Intervention Type
Drug
Intervention Name(s)
Qingkailing injection 40 ml
Primary Outcome Measure Information:
Title
Change from baseline in corticosteroids withdrawal rate at 24 weeks
Description
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 Outcome Measure Information:
Title
Change from baseline in Disease activity score in 28 joints(DAS28)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
General Hospital of Chengdu Military Area Command PLA
City
Chengdu
ZIP/Postal Code
610083
Country
China

12. IPD Sharing Statement

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

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