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

Not Applicable

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: Luo-Fu-Shan Plaster; Drug: The placebo 10g

• Registration Number: NCT04884880
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-04-30
• Status Verified: 2021-05
• Study First Submitted QC: 2021-05-07
• Last Update Submitted: 2021-05-07
• Study First Posted: 2021-05-13
• Last Update Posted: 2021-05-13
• Study Start: 2021-05-14
• Primary Completion: 2021-12-31
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Luo-Fu-Shan Plaster 10g	Luo-Fu-Shan Plaster	10g，once daily，4 weeks
Placebo	The placebo 10g	10g，once daily，4 weeks

Primary Outcome Measures

Name	Time	Method
The changes of Visual Analogue Scale(VAS) pain score	Day 1 to Week 4	The changes of Visual Analogue Scale(VAS) pain score of global health status, the patient's assessment of pain on a visual analogue scale.; The score their pain intensity in the most affected joint on a 0-10 cm Visual Analogue Scale Score (VAS), ranging from no pain (0) to extremely pain (10).

Secondary Outcome Measures

Name	Time	Method
The changes of the Disease Activiyu Score (DAS28)	Day 1 to Week 4	The changes of the Disease Activity Score (DAS28).The score their pain intensity in the most affected joint on a 0-10 cm Disease Activity Score (DAS28), ranging from no pain (0) to extremely pain (10).

Trial Locations

Locations (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, Beijing, China