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A randomized double-blind controlled study of Guizhi Decoction in the treatment of early rheumatoid arthritis based on ultrasonic evaluatio

Phase 1
Recruiting
Conditions
Rheumatoid arthritis
Registration Number
ITMCTR2000003615
Lead Sponsor
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Meet the diagnostic criteria for RA; Meet the diagnostic criteria for active RA.
2. Aged 18-75 years with a course of disease less than 1 year.
3. Disease Activity Score in 28 joints-Erythrocyte Sedimentation Rate (DAS28-ESR) >= 2.6 (rounded to 1 decimal place).
4. Patients receiving NSAIDs and hormone therapy were given a stable dose for at least 30 days before entering the trial, and remained the same for the rest of the treatment.
5. Patients receiving other DMARDs must be interrupted for at least 30 days before entering the trial.

Exclusion Criteria

1. Patients with interstitial lung disease; Accompanied by severe elevations of liver enzymes.
2. Women who are pregnant, breast-feeding or who have recently prepared for childbirth.
3. Persons who are allergic or sensitized to the test drugs.
4. Patients with severe primary diseases of the heart, liver, kidneys, brain, endocrine system and hematopoietic system, psychiatric disorders, etc.
5. At the same time with other rheumatic diseases such as systemic lupus erythematosus, Sjogren's syndrome, myositis and so on.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
S7;DAS28;Joint tenderness count;CRP;Evaluation of TCM syndrome curative effect;VAS;routine blood test;ESR;Joint swelling count;
Secondary Outcome Measures
NameTimeMethod
sCD14;TIMP;MMP3;CD14+;
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