CClinicalTrials.gg
Status unknownNCT04884880Updated May 13, 2021

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

An interventional study of Luo-Fu-Shan Plaster and The placebo 10g in Arthritis, Rheumatoid, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-05-13.

Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Arthritis, Rheumatoid

Keywords

  • Rheumatoid Arthritis
  • External therapy
  • Herb medicine
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In context

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's planned enrollment of 180 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Browse Arthritis studies →

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences is the lead sponsor of 133 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Luo-Fu-Shan Plaster 10g

    10g,once daily,4 weeks

    Drug: Luo-Fu-Shan Plaster

  • Placebo comparator
    Placebo

    10g,once daily,4 weeks

    Drug: The placebo 10g

Interventions

  • DrugLuo-Fu-Shan Plaster

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

  • DrugThe placebo 10g

    Placebo 10g,once daily,4 weeks

    Also known as: placebo

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What researchers measure

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).

    Time frame: Day 1 to Week 4

Secondary outcomes

  1. 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).

    Time frame: Day 1 to Week 4

Other outcomes

  1. 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).

    Time frame: Day1 to Week 4

  2. 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.

    Time frame: Day 1 to Week 4

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Study locations

1 site
  • Guang'anmen Hospital of China Academy of Chinese Medical Sciences
    Beijing, Beijing, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04884880
Lead sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Responsible party
Quan Jiang (Director,Devision of Rhenumatology, Guang'anmen Hospital of China Academy of Chinese Medical Sciences) — Principal investigator
First posted
May 13, 2021
Start date
May 14, 2021 (estimated)
Primary completion
Dec 31, 2021 (estimated)
Completion
Apr 30, 2022 (estimated)
Last update
May 13, 2021

Study contacts

Jiang Quan, PhD
Contact
doctorjq@126.com
86-010-88001132
Jiang Quan, PhD
principal investigator · Guang'anmen Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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