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

Arthritis, Rheumatoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04884880
• Other study ID #: 2020006P4A01
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 14, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2021
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Jiang Quan, PhD
• Phone: 86-010-88001132
• Email: doctorjq[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: April 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• Luo-Fu-Shan Plaster
Luo-Fu-Shan Plaster 10g,once daily,4 weeks
• The placebo 10g
Placebo 10g,once daily,4 weeks

Locations

Country	Name	City	State
China	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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