Z161100001816046

About this trial

Last updated 7 years ago

Study ID

Z161100001816046

Status

Completed

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 65 Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 12 years ago

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.

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.

Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis