Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis
- Conditions
- Arthritis, Rheumatoid
- Interventions
- Drug: Placebo gel
- Registration Number
- NCT02818361
- Brief 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description topical TwHF gel group Topical tripterygium gel 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. placebo group Placebo gel Placebo recipe composes viscous agent which matches by the sucrose. The usage and dosage of topical TwHF and placebo are the same.
- Primary Outcome Measures
Name Time Method Twenty percent improvement in the American College of Rheumatology criteria Week 4.
- Secondary Outcome Measures
Name Time Method The changes of the 28-joint count Disease Activity Score (DAS28) Week 4 and week 8. The changes of Visual Analogue Scale (VAS) pain score Week 1, 2, 3, 4, 5, 6, 7, and 8. The change of knee articular cavity effusion as assessed by MSUS Week 2, 4, and 8. Articular cavity effusion adopts binary evaluation, namely: 0: normal, 1: abnormal.
The change of knee bone erosion classification as assessed by MSUS Week 2, 4, and 8. Bone erosion classification adopts binary evaluation, namely: 0: normal, 1: abnormal.
Fifty percent improvement in the American College of Rheumatology criteria Week 4 and week 8. 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.
The change of knee synovitis classification as assessed by musculoskeletal ultrasound (MSUS) Week 2, 4, and 8. 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.
The change of knee synovial hyperplasia classification as assessed by MSUS Week 2, 4, and 8. 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.
Trial Locations
- Locations (1)
Guang'anmen Hospital
🇨🇳Beijing, Beijing, China