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

NCT ID: NCT04884880

Last Updated: 2021-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-14

Study Completion Date

2022-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Luo-Fu-Shan Plaster 10g

10g,once daily,4 weeks

Group Type EXPERIMENTAL

Luo-Fu-Shan Plaster

Intervention Type DRUG

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

Placebo

10g,once daily,4 weeks

Group Type PLACEBO_COMPARATOR

The placebo 10g

Intervention Type DRUG

Placebo 10g,once daily,4 weeks

Interventions

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Luo-Fu-Shan Plaster

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

Intervention Type DRUG

The placebo 10g

Placebo 10g,once daily,4 weeks

Intervention Type DRUG

Other Intervention Names

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placebo

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Quan Jiang

Director,Devision of Rhenumatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiang Quan, PhD

Role: PRINCIPAL_INVESTIGATOR

Guang'anmen Hospital

Locations

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Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Jiang Quan, PhD

Role: CONTACT

86-010-88001132

Other Identifiers

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2020006P4A01

Identifier Type: -

Identifier Source: org_study_id

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