NCT02818361

Topical Tripterygium Wilfordii Gel for Treatment in Patients With Moderate Activity Rheumatoid Arthritis

Completed NA Last updated 19 November 2018

What this trial tests

NA trial testing Topical tripterygium gel in Arthritis, Rheumatoid in 70 participants. Completed in 1 December 2013.

Timeline

1 April 2012

Primary endpoint
1 March 2013

1 December 2013

Quick facts

Lead sponsor	Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	70
Start date	1 April 2012
Primary completion	1 March 2013
Estimated completion	1 December 2013
Sites	1 location across China

Drugs / interventions tested

• Topical tripterygium gel — full drug profile →
• Placebo gel

Conditions studied

• Arthritis, Rheumatoid — all drugs for Arthritis, Rheumatoid →

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Who can join

Adults 18 to 65, any sex, with Arthritis, Rheumatoid. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Twenty percent improvement in the American College of Rheumatology criteria
  Time frame: Week 8.
  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 Assessm
• Twenty percent improvement in the American College of Rheumatology criteria
  Time frame: Week 4.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A comprehensive review of <i>Tripterygium wilfordii</i> hook. f. in the treatment of rheumatic and autoimmune diseases: Bioactive compounds, mechanisms of action, and future directions.
   Shan Y, Zhao J, Wei K, Jiang P, et al · · 2023 · cited 29× · PMID 38027004 · DOI 10.3389/fphar.2023.1282610
2. 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.
   Jiang Q, Tang XP, Chen XC, Xiao H, et al · · 2017 · cited 10× · PMID 28870177 · DOI 10.1186/s12906-017-1957-z