Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

Official title:

Topical Tripterygium Wilfordii Gel for Treatment in Patients With Moderate Activity Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02818361
• Other study ID #: Z161100001816046
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: November 2018
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• Topical tripterygium gel

• Placebo gel

Locations

Country	Name	City	State
China	Guang'anmen Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 8.
Primary	Twenty percent improvement in the American College of Rheumatology criteria		Week 4.
Secondary	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.	Week 4 and week 8.
Secondary	The changes of the 28-joint count Disease Activity Score (DAS28)		Week 4 and week 8.
Secondary	The changes of Visual Analogue Scale (VAS) pain score		Week 1, 2, 3, 4, 5, 6, 7, and 8.
Secondary	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.	Week 2, 4, and 8.
Secondary	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.	Week 2, 4, and 8.
Secondary	The change of knee articular cavity effusion as assessed by MSUS	Articular cavity effusion adopts binary evaluation, namely: 0: normal, 1: abnormal.	Week 2, 4, and 8.
Secondary	The change of knee bone erosion classification as assessed by MSUS	Bone erosion classification adopts binary evaluation, namely: 0: normal, 1: abnormal.	Week 2, 4, and 8.