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

Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled Clinical Trial of Luo-Fu-Shan Plaster in the Treatment of Rheumatoid Arthritis

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

Study Overview

• Status: Not yet recruiting
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Drug: Luo-Fu-Shan Plaster; Drug: The placebo 10g

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 Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiang Quan, PhD; Phone Number: 86-010-88001132; Email: doctorjq@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Luo-Fu-Shan Plaster 10g; 10g，once daily，4 weeks	Drug: Luo-Fu-Shan Plaster; Luo-Fu-Shan Plaster 10g，once daily，4 weeks
Placebo Comparator: Placebo; 10g，once daily，4 weeks	Drug: The placebo 10g; Placebo 10g，once daily，4 weeks; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes of Visual Analogue Scale(VAS) pain score	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).	Day 1 to Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The changes of the Disease Activiyu Score (DAS28)	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).	Day 1 to Week 4

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The score of the Health Assessment Questionnaire (HAQ-DI)	the patient's assessment of function using a modified version of the Health Assessment Questionnaire (HAQ).The score their level, ranging from no difficuties(0),some difficulties(1),a lot of difficuties(2) to coud not finish(3).	Day1 to Week 4
The score of the RA-PRO	the patient's assessment of function using a modified version of the RA-PRO which ranging from 0 to 3.	Day 1 to Week 4

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Investigators: Principal Investigator: Jiang Quan, PhD, Guang'anmen hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): May 14, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: May 7, 2021
• First Posted (Actual): May 13, 2021

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; External therapy; Herb medicine
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 2020006P4A01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No