A Study to Assess Efficacy and Safety of Wangbi Capsule in Patients With Rheumatoid Arthritis

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Other

Identifiers

NCT04652791

20201005V1

Details and patient eligibility

About

The aim of this multi-center, prospective, non-interventional cohort study is to evaluate the efficacy and safety of Wangbi capsule for rheumatoid arthritis patients in the real-world setting.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has a diagnosis of RA as defined by the ACR/EULAR 2010 classification criteria
• Patients older than 18
• Syndrome of insufficiency of liver and kidney or syndrome of cold and dampness defined by traditional Chinese medicine

Exclusion criteria

• Patients who are pregnant or breast feeding at enrolment
• History of malignancy prior to screening
• Patients with severe or poorly controlled chronic diseases such as hypertension, diabetes and coronary heart disease
• Patients taking biological agents, > 10mg prednisone (or equivalent amount of other glucocorticoids) ，more than 2 kinds of DMARDs or similar TCM drug like Wangbi Capsule

Trial design

1,200 participants in 2 patient groups

Wangbi Capsule

Description:

Patients who are taking Wangbi Capsule for the treatment.

Other drugs

Description:

Patients who are not taking Wangbi Capsule for the treatment.