Guizhi Shaoyao Zhimu Decoction Combined With Methotrexate in the Treatment of Early Rheumatoid Arthritis

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to evaluate the effectiveness and safety of Guizhi Shaoyao Zhimu decoction in combination with methotrexate for the treatment of early RA patients and a parallel-group, single-center randomized controlled clinical study was designed.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing University of Chinese Medicine
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• Patients aged 16-70 years old;

• Patients who meet the diagnostic criteria of 2010 ACR/EULAR .

• Patients who meet the diagnostic criteria of cold pattern.

• Disease activity score(DAS28) ≤5.2.

Exclusion Criteria:

• Patients accompanied with other rheumatic diseases or severe pain due to other medical conditions, such as diabetic pain or post-herpetic neuralgia;

• Patients with joint dysfunction and the X-ray score of wrists is grade IV;

• Patients accompanied with mental and psychological disorders such as cognitive impairment, depression, anxiety, physical dysfunction, cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating disease and other central nervous system diseases.

• Patients accompanied with organ injury or malignant tumors, disorders of the cardiovascular system, liver(ALT/AST>3 times higher than the upper limit of normal), kidneys(Ccr<60ml/min), brain, or hematopoietic system.

• Pregnant and lactating women.

• Patients are participation in any other clinical trials.

• Patients who are allergic to the drugs used in this study.