Efficacy and Safety of Luo-Fu-Shan Plaster in Patients With Rheumatoid Arthritis

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Luo-Fu-Shan Plaster; Drug: The placebo 10g

Study type: Interventional

Funder types: Other

Identifiers

NCT04884880

2020006P4A01

Details and patient eligibility

About

The aim of this study is to assess the efficacy and safety of Luo-Fu-Shan Plaster in patients with Rheumatoid Arthritis.

Full description

The investigators are inspired by Chinese traditonal herb, an therapy for thousands of years, and take its advantage to make Luo-Fu-Shan Plaster in order to get an effective and safe treatment for active RA patients. The study is a multicenter, randomized, double-blind, placebo-controlled trial.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female subjects aged 18 to 75 years (time of get informed consent)
• Documented diagnosis of rheumatoid arthritis, as defined by the American Rheumatism Association 1987 Revised Criteria.
• Documented diagnosis of damp-heat syndrome according to Traditional Chinese Medicine.
• If patients are receiving Disease-modifying anti-rheumatic drugs (DMARDs), then the doses should have been kept stable for at least 12 weeks.
• If patients are receiving non-steroidal anti-inflammatory drugs (NSAIDs) or orally Chinese herbal medicine, then the doses should have been kept stable for at least 4 weeks.

Exclusion criteria

• Skin allergies or broken skin;
• Taking glucocorticoids,more than 10 mg daily.
• Female patients who are pregnant, breast-feeding or planed to be pregnant;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

Luo-Fu-Shan Plaster 10g

Experimental group

Description:

10g，once daily，4 weeks

Treatment:

Drug: Luo-Fu-Shan Plaster

Placebo

Placebo Comparator group

Description:

10g，once daily，4 weeks

Treatment:

Drug: The placebo 10g