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

NCT04884880 | Unknown

• 1 other identifier: 2020006P4A01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid Arthritis; External therapy; Herb medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The changes of the Disease Activiyu Score (DAS28)

  Day 1 to Week 4

Other Outcomes (2)

• The score of the Health Assessment Questionnaire (HAQ-DI)

  Day1 to Week 4

• The score of the RA-PRO

  Day 1 to Week 4

Study Arms (2)

Luo-Fu-Shan Plaster 10g

EXPERIMENTAL

10g，once daily，4 weeks

Drug: Luo-Fu-Shan Plaster

Placebo

PLACEBO COMPARATOR

10g，once daily，4 weeks

Drug: The placebo 10g

Interventions

Luo-Fu-Shan Plaster DRUG

Luo-Fu-Shan Plaster 10g，once daily，4 weeks

Luo-Fu-Shan Plaster 10g

The placebo 10g DRUG

Placebo 10g，once daily，4 weeks

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jiang Quan, PhD

  Guang'anmen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiang Quan, PhD

CONTACT

86-010-88001132; doctorjq@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,Devision of Rhenumatology

Model Details: 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.

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 13, 2021
• Study Start: May 14, 2021
• Primary Completion: December 31, 2021
• Study Completion: April 30, 2022
• Last Updated: May 13, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)