Clinical trial NCT02818361: Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis
Official title: Topical Tripterygium Wilfordii Gel for Treatment in Patients With Moderate Activity Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
Tripterygium wilfordii Hook F
double-blinded
randomized controlled trial
Tripterygium
Administration
Topical
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Twenty percent improvement in the American College of Rheumatology criteria
timeFrame: Week 8.
measure: Twenty percent improvement in the American College of Rheumatology criteria
timeFrame: Week 4.
Secondary outcomes:
measure: Fifty percent improvement in the American College of Rheumatology criteria
timeFrame: Week 4 and week 8.
measure: The changes of the 28-joint count Disease Activity Score (DAS28)
timeFrame: Week 4 and week 8.
measure: The changes of Visual Analogue Scale (VAS) pain score
timeFrame: Week 1, 2, 3, 4, 5, 6, 7, and 8.
measure: The change of knee synovitis classification as assessed by musculoskeletal ultrasound (MSUS)
timeFrame: Week 2, 4, and 8.
measure: The change of knee synovial hyperplasia classification as assessed by MSUS
timeFrame: Week 2, 4, and 8.
measure: The change of knee articular cavity effusion as assessed by MSUS
timeFrame: Week 2, 4, and 8.
measure: The change of knee bone erosion classification as assessed by MSUS
timeFrame: Week 2, 4, and 8.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital
state: Beijing
Study officials:
affiliation: Rheumatology Department
name: Quan Jiang, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.