Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis

NCT ID: NCT02818361

Last Updated: 2018-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-12-31

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.

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

topical TwHF gel group

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.

Group Type: EXPERIMENTAL

Topical tripterygium gel

Intervention Type: DRUG

placebo group

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

Group Type: PLACEBO_COMPARATOR

Placebo gel

Intervention Type: DRUG

Interventions

Topical tripterygium gel

Intervention Type: DRUG

Placebo gel

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Quan Jiang

Chief, Rheumatology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Quan Jiang, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Rheumatology Department

Locations

Guang'anmen Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 28870177 (View on PubMed)

Other Identifiers

Z161100001816046

Identifier Type: -

Identifier Source: org_study_id