Modified Zhiwang Decoction Combined With Methotrexate in the Treatment of Early Rheumatoid Arthritis

Beijing University of Chinese Medicine

Status and phase

Enrolling

Early Phase 1

Conditions

Arthritis, Rheumatoid

Treatments

Drug: Modified Zhiwang Decoction Combined with methotrexate

Drug: Methotrexate

Study type

Interventional

Funder types

Other

Identifiers

NCT05508815

zliubo

Details and patient eligibility

About

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

Full description

Rheumatoid Arthritis(RA) is a progressive inflammatory autoimmune disease characterized by chronic systemic inflammation, which can cause swelling, stiffening and articular cartilage and bone destruction. Early diagnosis and treatment in RA can improve outcomes and slow progression of joint damage. Modified Zhiwang Decoction(MZWD) has great curative effects for treating RA. However, few randomized clinical trials(RCTs) have evaluated the effectiveness of MZWD for the treatment of early RA. Therefore, a parallel-group randomized controlled trial was designed to evaluate the efficacy and safety of MZWD combined with methotrexate on early RA.

Enrollment

150 estimated patients

Sex

All

Ages

16 to 70 years old

Volunteers

No Healthy Volunteers

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.