Arthritis, RheumatoidNCT02818361
Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis
A study testing Topical tripterygium gel in people with Arthritis, Rheumatoid, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
Tripterygium wilfordii Hook F (TwHF), a traditional Chinese herb, is widely used in China for treating Rheumatoid Arthritis (RA), but limited only for elderly RA patients because of its reproductive system toxicity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Topical tripterygium gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- Apr 2012to Dec 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Patients, men and women, must age from 18 to 65 years old.
- Patients must have moderately active RA based on the criteria of the DAS-28 score from 3.2 to 5.1.
- 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 TwHF agents, glucocorticoids and biological agents;
- Female patients who are pregnant, breast-feeding or planed to be pregnant;
- Subjects suffering serious hyperlipidemia, hyperglycemia, diabetes mellitus, cardiovascular diseases, gastrointestinal problems or liver and renal failure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Tripterygium Wilfordii Gel for Treatment in Patients With Moderate Activity Rheumatoid Arthritis
Tripterygium wilfordii Hook F (TwHF), a traditional Chinese herb, is widely used in China for treating Rheumatoid Arthritis (RA), but limited only for elderly RA patients because of its reproductive system toxicity. The investigators are inspired by Chinese external therapy, an immemorial therapy for thousands of years, and take its advantage to make TwHF topically in order to get an effective and safe treatment for active RA patients.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Topical tripterygium gel, Placebo gel
- Keywords
- Rheumatoid Arthritis, Tripterygium wilfordii Hook F, double-blinded, randomized controlled trial, Tripterygium, Administration, Topical
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical tripterygium gelDrug
Placebo gelDrug
| Study group | Role | What they receive |
|---|---|---|
| topical TwHF gel group | Experimental | Topical TwHF gel recipe composes Tripterygium wilfordii Hook F, Mangxiao (Mirabilite), Chuanxiong (Rhizoma Ligustici), Ruxiang (Olibanum), Moyao (M yrrh) (prescription proportion is 4:4:2:2:1).Each gel is 20 gram(g). TwHF gel is applied for 1st to 5th metacarpophalangeal joints, 1st to 5th proximal interphalangeal joints, wrists, knees and ankles 20g for 1 hour, once per day from week 0 through week 4 and 10g for 1 hour, once per day from week 5 through week 8. Receives: Drug: Topical tripterygium gel |
| placebo group | Placebo comparator | Placebo recipe composes viscous agent which matches by the sucrose. The usage and dosage of topical TwHF and placebo are the same. Receives: Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Twenty percent improvement in the American College of Rheumatology criteria
a patient must have 20% or greater improvement in both tender and swollen joints (28 tender and 28 swollen joints were assessed) and 20% or greater improvement in 3 or more of the following: the physician's or patient's assessment of global health status, the patient's assessment of pain on a visual analogue scale, the patient's assessment of function using a modified version of the Health Assessment Questionnaire (HAQ), and the erythrocyte sedimentation rate (ESR) or serum C-reactive protein (CRP) level.
Measured: Week 8.
Twenty percent improvement in the American College of Rheumatology criteria
Measured: Week 4.
Secondary outcomes (7)
Fifty percent improvement in the American College of Rheumatology criteria
a patient must have 50% or greater improvement in both tender and swollen joints (28 tender and 28 swollen joints were assessed) and 50% or greater improvement in 3 or more of the following: the physician's or patient's assessment of global health status, the patient's assessment of pain on a visual analogue scale, the patient's assessment of function using a modified version of the HAQ), and the ESR or CRP level.
Measured: Week 4 and week 8.
The changes of the 28-joint count Disease Activity Score (DAS28)
Measured: Week 4 and week 8.
The changes of Visual Analogue Scale (VAS) pain score
Measured: Week 1, 2, 3, 4, 5, 6, 7, and 8.
The change of knee synovitis classification as assessed by musculoskeletal ultrasound (MSUS)
Synovitis classification is specific as follows: 0 level, no doppler signal; level 1: three independent point or 2 successive or 1 and 2 in independent dot doppler signal; level 2: doppler signal < 50% of the synovial membrane area; level 3 doppler signal is the synovium in > 50% of the area.
Measured: Week 2, 4, and 8.
The change of knee synovial hyperplasia classification as assessed by MSUS
Synovial hyperplasia classification is specific as follows: 0 level, no synovial hyperplasia; level 1: synovial hyperplasia of mild, not more than bone surface high attachment; level 2: synovial hyperplasia more than bone surface high wire, but not more than the backbone; level 3: synovial hyperplasia more than bone surface peak wires, and extends along the backbone of the side.
Measured: Week 2, 4, and 8.
The change of knee articular cavity effusion as assessed by MSUS
Articular cavity effusion adopts binary evaluation, namely: 0: normal, 1: abnormal.
Measured: Week 2, 4, and 8.
The change of knee bone erosion classification as assessed by MSUS
Bone erosion classification adopts binary evaluation, namely: 0: normal, 1: abnormal.
Measured: Week 2, 4, and 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study startApr 2012
- Primary completionMar 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
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
- Quan Jiang, MD. PhD., Principal investigator, Rheumatology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818361
- Sponsor's protocol ID
- Z161100001816046
- Status last verified
- Nov 2018
- First submitted
- 15 Jun 2016
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jiang Q, Tang XP, Chen XC, Xiao H, Liu P, Jiao J. Will Chinese external therapy with compound Tripterygium wilfordii hook F gel safely control disease activity in patients with rheumatoid arthritis: design of a double-blinded randomized controlled trial. BMC Complement Altern Med. 2017 Sep 5;17(1):444. doi: 10.1186/s12906-017-1957-z.
PubMed 28870177
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Tripterygium Wilfordii Gel for Treatment in Patients With Moderate Activity Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02818361
- Acronym / sponsor ID
- Z161100001816046
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Rheumatoid Arthritis, Tripterygium wilfordii Hook F, double-blinded, randomized controlled trial, Tripterygium, Administration, Topical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 29 Jun 2016 (estimated)
- 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.
Tripterygium wilfordii Hook F (TwHF), a traditional Chinese herb, is widely used in China for treating Rheumatoid Arthritis (RA), but limited only for elderly RA patients because of its reproductive system toxicity. The investigators are inspired by Chinese external therapy, an immemorial therapy for thousands of years, and take its advantage to make TwHF topically in order to get an effective and safe treatment for active RA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| topical TwHF gel group | Experimental | Drug: Topical tripterygium gelTopical TwHF gel recipe composes Tripterygium wilfordii Hook F, Mangxiao (Mirabilite), Chuanxiong (Rhizoma Ligustici), Ruxiang (Olibanum), Moyao (M yrrh) (prescription proportion is 4:4:2:2:1).Each gel is 20 gram(g). TwHF gel is applied for 1st to 5th metacarpophalangeal joints, 1st to 5th proximal interphalangeal joints, wrists, knees and ankles 20g for 1 hour, once per day from week 0 through week 4 and 10g for 1 hour, once per day from week 5 through week 8. |
| placebo group | Placebo comparator | Drug: Placebo gelPlacebo recipe composes viscous agent which matches by the sucrose. The usage and dosage of topical TwHF and placebo are the same. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Patients, men and women, must age from 18 to 65 years old.
- Patients must have moderately active RA based on the criteria of the DAS-28 score from 3.2 to 5.1.
- If patients are receiving Disease-modifying anti-rheumatic drugs (DMARDs), then the doses should have been kept stable for at least 12 weeks.
Key exclusion criteria (4 listed)
- Skin allergies or broken skin;
- Taking TwHF agents, glucocorticoids and biological agents;
- Female patients who are pregnant, breast-feeding or planed to be pregnant;
- Subjects suffering serious hyperlipidemia, hyperglycemia, diabetes mellitus, cardiovascular diseases, gastrointestinal problems or liver and renal failure.
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 |
|---|---|---|
| Topical tripterygium gel | Drug | topical TwHF gel group |
| Placebo gel | Drug | placebo group |
Primary outcome
Twenty percent improvement in the American College of Rheumatology criteria
Time frame: Week 8.
a patient must have 20% or greater improvement in both tender and swollen joints (28 tender and 28 swollen joints were assessed) and 20% or greater improvement in 3 or more of the following: the physician's or patient's assessment of global health status, the patient's assessment of pain on a visual analogue scale, the patient's assessment of function using a modified version of the Health Assessment Questionnaire (HAQ), and the erythrocyte sedimentation rate (ESR) or serum C-reactive protein (CRP) level.
Twenty percent improvement in the American College of Rheumatology criteria
Time frame: Week 4.
7 secondary outcomes
Fifty percent improvement in the American College of Rheumatology criteria
Time frame: Week 4 and week 8.
The changes of the 28-joint count Disease Activity Score (DAS28)
Time frame: Week 4 and week 8.
The changes of Visual Analogue Scale (VAS) pain score
Time frame: Week 1, 2, 3, 4, 5, 6, 7, and 8.
The change of knee synovitis classification as assessed by musculoskeletal ultrasound (MSUS)
Time frame: Week 2, 4, and 8.
The change of knee synovial hyperplasia classification as assessed by MSUS
Time frame: Week 2, 4, and 8.
The change of knee articular cavity effusion as assessed by MSUS
Time frame: Week 2, 4, and 8.
The change of knee bone erosion classification as assessed by MSUS
Time frame: Week 2, 4, and 8.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Derived from this study: PubMed 28870177Jiang Q, Tang XP, Chen XC, Xiao H, Liu P, Jiao J. Will Chinese external therapy with compound Tripterygium wilfordii hook F gel safely control disease activity in patients with rheumatoid arthritis: design of a double-blinded randomized controlled trial. BMC Complement Altern Med. 2017 Sep 5;17(1):444. doi: 10.1186/s12906-017-1957-z.
- 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.
Quan Jiang, MD. PhD. principal investigator
Rheumatology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical tripterygium gel 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 20 Nov 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Twenty percent improvement in the American College of Rheumatology criteria (time frame: Week 8.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02818361, which also lists 1 linked publication.
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 20 Nov 2018.