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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036141
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-10-01
Completion date
Unknown
Last updated
2021-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
DAS28;Joint swelling count;Joint tenderness count;VAS;Evaluation of TCM syndrome curative effect;routine blood test;ESR;CRP;US7;

Secondary

MeasureTime frame
MMP3;TIMP;sCD14;CD14+;

Countries

China

Contacts

Public ContactYang Guanghui

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

dryanggh@126.com+86 13311793010

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026