- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02818361
Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis
November 19, 2018 updated by: Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100053
- Guang'anmen hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: topical TwHF gel group
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.
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PLACEBO_COMPARATOR: placebo group
Placebo recipe composes viscous agent which matches by the sucrose.
The usage and dosage of topical TwHF and placebo are the same.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Week 8.
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Twenty percent improvement in the American College of Rheumatology criteria
Time Frame: Week 4.
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Week 4.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fifty percent improvement in the American College of Rheumatology criteria
Time Frame: Week 4 and week 8.
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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.
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Week 4 and week 8.
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The changes of the 28-joint count Disease Activity Score (DAS28)
Time Frame: Week 4 and week 8.
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Week 4 and week 8.
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The changes of Visual Analogue Scale (VAS) pain score
Time Frame: Week 1, 2, 3, 4, 5, 6, 7, and 8.
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Week 1, 2, 3, 4, 5, 6, 7, and 8.
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The change of knee synovitis classification as assessed by musculoskeletal ultrasound (MSUS)
Time Frame: Week 2, 4, and 8.
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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.
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Week 2, 4, and 8.
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The change of knee synovial hyperplasia classification as assessed by MSUS
Time Frame: Week 2, 4, and 8.
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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.
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Week 2, 4, and 8.
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The change of knee articular cavity effusion as assessed by MSUS
Time Frame: Week 2, 4, and 8.
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Articular cavity effusion adopts binary evaluation, namely: 0: normal, 1: abnormal.
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Week 2, 4, and 8.
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The change of knee bone erosion classification as assessed by MSUS
Time Frame: Week 2, 4, and 8.
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Bone erosion classification adopts binary evaluation, namely: 0: normal, 1: abnormal.
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Week 2, 4, and 8.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 1, 2012
Primary Completion (ACTUAL)
March 1, 2013
Study Completion (ACTUAL)
December 1, 2013
Study Registration Dates
First Submitted
June 15, 2016
First Submitted That Met QC Criteria
June 28, 2016
First Posted (ESTIMATE)
June 29, 2016
Study Record Updates
Last Update Posted (ACTUAL)
November 20, 2018
Last Update Submitted That Met QC Criteria
November 19, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Z161100001816046
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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