Arthritis, RheumatoidNCT04884880
Efficacy and Safety of Luo-Fu-Shan Plaster in Patients With Rheumatoid Arthritis
A study testing Luo-Fu-Shan Plaster in people with Arthritis, Rheumatoid, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
The aim of this study is to assess the efficacy and safety of Luo-Fu-Shan Plaster in patients with Rheumatoid Arthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Luo-Fu-Shan Plaster
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2021to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Skin allergies or broken skin;
- Taking glucocorticoids,more than 10 mg daily.
- Female patients who are pregnant, breast-feeding or planed to be pregnant;
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality
About this study
Official title: Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled Clinical Trial of Luo-Fu-Shan Plaster in the Treatment of Rheumatoid Arthritis
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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Luo-Fu-Shan Plaster, The placebo 10g
- Keywords
- Rheumatoid Arthritis, External therapy, Herb medicine
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Luo-Fu-Shan PlasterDrug
Luo-Fu-Shan Plaster 10g，once daily，4 weeks
The placebo 10gDrug
Also called placebo
Placebo 10g，once daily，4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Luo-Fu-Shan Plaster 10g | Experimental | 10g，once daily，4 weeks Receives: Drug: Luo-Fu-Shan Plaster |
| Placebo | Placebo comparator | 10g，once daily，4 weeks Receives: Drug: The placebo 10g |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Day 1 to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start14 May 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jiang Quan, PhD, Principal investigator, Guang'anmen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884880
- Sponsor's protocol ID
- 2020006P4A01
- Status last verified
- May 2021
- First submitted
- 30 Apr 2021
- Last updated
- 13 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicentre, Randomized, Double-blind, Placebo-controlled Clinical Trial of Luo-Fu-Shan Plaster in the Treatment of Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT04884880
- Acronym / sponsor ID
- 2020006P4A01
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Rheumatoid Arthritis, External therapy, Herb medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 14 May 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Luo-Fu-Shan Plaster 10g | Experimental | Drug: Luo-Fu-Shan Plaster10g，once daily，4 weeks |
| Placebo | Placebo comparator | Drug: The placebo 10g10g，once daily，4 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Skin allergies or broken skin;
- Taking glucocorticoids,more than 10 mg daily.
- Female patients who are pregnant, breast-feeding or planed to be pregnant;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Luo-Fu-Shan PlasterLuo-Fu-Shan Plaster 10g，once daily，4 weeks | Drug | Luo-Fu-Shan Plaster 10g |
| The placebo 10gAlso: placeboPlacebo 10g，once daily，4 weeks | Drug | Placebo |
Primary outcome
The changes of Visual Analogue Scale(VAS) pain score
Time frame: Day 1 to Week 4
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).
1 secondary outcome
The changes of the Disease Activiyu Score (DAS28)
Time frame: Day 1 to Week 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiang Quan, PhD principal investigator
Guang'anmen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Luo-Fu-Shan Plaster in people with Arthritis, Rheumatoid, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Quan, PhD (86-010-88001132, doctorjq@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of Visual Analogue Scale(VAS) pain score (time frame: Day 1 to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2021.