Back to resultsEfficacy and Safety of Luo-Fu-Shan Plaster in Patients With Rheumatoid Arthritis
Primary Purpose
Arthritis, Rheumatoid
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Luo-Fu-Shan Plaster
The placebo 10g
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Rheumatoid Arthritis, External therapy, Herb medicine
Eligibility Criteria
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;
Sites / Locations
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Luo-Fu-Shan Plaster 10g
Placebo
Arm Description
10g，once daily，4 weeks
10g，once daily，4 weeks
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT04884880
First Posted
April 30, 2021
Last Updated
May 7, 2021
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04884880
Brief Title
Efficacy and Safety of Luo-Fu-Shan Plaster in Patients With Rheumatoid Arthritis
Official Title
Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled Clinical Trial of Luo-Fu-Shan Plaster in the Treatment of Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Rheumatoid Arthritis, External therapy, Herb medicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
180 subjects will be randomized to two parallel groups (90 subjects per group) to receive Luo-Fu-Shan Plaster 10g once daily. Placebo will be administered to individuals randomized to that treatment group in a form identical to the Luo-Fu-Shan Plaster. The first investigational medicinal product dose will be administered the day after the randomization.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Luo-Fu-Shan Plaster 10g
Arm Type
Experimental
Arm Description
10g，once daily，4 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
10g，once daily，4 weeks
Intervention Type
Drug
Intervention Name(s)
Luo-Fu-Shan Plaster
Intervention Description
Luo-Fu-Shan Plaster 10g，once daily，4 weeks
Intervention Type
Drug
Intervention Name(s)
The placebo 10g
Other Intervention Name(s)
placebo
Intervention Description
Placebo 10g，once daily，4 weeks
Primary Outcome Measure Information:
Title
The changes of Visual Analogue Scale(VAS) pain score
Description
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).
Time Frame
Day 1 to Week 4
Secondary Outcome Measure Information:
Title
The changes of the Disease Activiyu Score (DAS28)
Description
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).
Time Frame
Day 1 to Week 4
Other Pre-specified Outcome Measures:
Title
The score of the Health Assessment Questionnaire (HAQ-DI)
Description
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).
Time Frame
Day1 to Week 4
Title
The score of the RA-PRO
Description
the patient's assessment of function using a modified version of the RA-PRO which ranging from 0 to 3.
Time Frame
Day 1 to Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Quan, PhD
Phone
86-010-88001132
Email
doctorjq@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Quan, PhD
Organizational Affiliation
Guang'anmen Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy and Safety of Luo-Fu-Shan Plaster in Patients With Rheumatoid Arthritis
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