Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis

NCT02818361 | Completed

• 1 other identifier: Z161100001816046
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

Rheumatoid Arthritis; Tripterygium wilfordii Hook F; double-blinded; randomized controlled trial; Tripterygium; Administration; Topical

Outcome Measures

Primary Outcomes (2)

• 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.

• Twenty percent improvement in the American College of Rheumatology criteria

  Week 4.

Secondary Outcomes (7)

• Fifty percent improvement in the American College of Rheumatology criteria

  Week 4 and week 8.

• The changes of the 28-joint count Disease Activity Score (DAS28)

  Week 4 and week 8.

• The changes of Visual Analogue Scale (VAS) pain score

  Week 1, 2, 3, 4, 5, 6, 7, and 8.

• The change of knee synovitis classification as assessed by musculoskeletal ultrasound (MSUS)

  Week 2, 4, and 8.

• The change of knee synovial hyperplasia classification as assessed by MSUS

  Week 2, 4, and 8.

Study Arms (2)

topical TwHF gel group

EXPERIMENTAL

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.

Drug: Topical tripterygium gel

placebo group

PLACEBO COMPARATOR

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

Drug: Placebo gel

Interventions

Topical tripterygium gel DRUG

topical TwHF gel group

Placebo gel DRUG

placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (1)

• 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.

  PMID: 28870177 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Quan Jiang, MD. PhD.

  Rheumatology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Rheumatology Department

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 29, 2016
• Study Start: April 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2013
• Last Updated: November 20, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)