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Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis

G

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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