Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Completed

Conditions: Arthritis, Rheumatoid

Treatments: Drug: Topical tripterygium gel; Drug: Placebo gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02818361

Z161100001816046

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

topical TwHF gel group

Experimental group

Description:

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.

Treatment:

Drug: Topical tripterygium gel

placebo group

Placebo Comparator group

Description:

Placebo recipe composes viscous agent which matches by the sucrose. The usage and dosage of topical TwHF and placebo are the same.

Treatment:

Drug: Placebo gel