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

NCT ID: NCT02264301

Last Updated: 2017-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-12-31

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Puerarin injection 400 mg

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

Group Type ACTIVE_COMPARATOR

Puerarin injection 400 mg

Intervention Type DRUG

Qingkailing injection 40 ml

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

Group Type EXPERIMENTAL

Qingkailing injection 40 ml

Intervention Type DRUG

Interventions

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Puerarin injection 400 mg

Intervention Type DRUG

Qingkailing injection 40 ml

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chengdu PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yang Min

Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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General Hospital of Chengdu Military Area Command PLA

Chengdu, , China

Site Status

Countries

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China

Other Identifiers

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QKL20140588

Identifier Type: -

Identifier Source: org_study_id

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