Skip to main content
OpenTrials
Completed

NCT Number: NCT01961505

Topical Compound Tripterygium Wilfordii Hook F for Patients With Active Rheumatoid Arthritis

Rheumatoid Arthritis (RA) is an autoimmune disease that results in a chronic inflammatory disorder that may affect many synovial joints, and may cause serious disability. It has been confirmed that Tripterygium wilfordii Hook F has effects of anti-inflammatory, immunosuppressive and cartilage protection. This is a prospective randomized controlled study to evaluated the efficacy and safety of external application with compound Tripterygium wilfordii Hook F in treating of patients with rheumatoid arthritis (RA).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Active Rheumatoid Arthritis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented diagnosis of rheumatoid arthritis, as defined by the American Rheumatism Association 1987 Revised Criteria or European League Against Rheumatism criteria (2009).
  • Patients must have moderately to severely active RA,and the DAS-28 score should be from 3.2 to 5.1.
  • If taking disease modifying antirheumatic drug (DMARDs)(e.g.Methotrexate), subject must have been on a stable dose for ≥ 3 months prior to randomization.
  • If taking non-steroidal anti-inflammatory drugs (NSAIDs), subject must have been on a stable dose for ≥ 4 weeks prior to randomization.
  • 16 to 65 years old, having signed the informed consent.

Exclusion criteria

  • Patients who have skin burst or allergies.
  • Patients with sever diseases in Cardiovascular, brain, lung, liver, kidney and hematopoietic system.
  • Patients who have been treated by tripterygium, hormones or biological agents.
  • Patients who have not been treated by DMARDs before.
  • Patients who are unwilling to comply with all study procedures.

Treatment and study plan

Topical compound tripterygium

Drug

Topical compound tripterygium was applied for the pain and swollen joints on non-woven fabric for 1 hour, twice per day.

Placebo

Drug

The topical placebo recipe composes viscous agent which matches by the sucrose, and the usage and dosage were the same as the topical compound tripterygium group.

Primary outcomes

  1. ACR20 criteria

    Time frame: Week 4

    To meet the 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 ESR or serum C-reactive protein (CRP) level.

Secondary outcomes

  1. ACR50 criteria

    Time frame: Week 4

    To meet the criteria, a patient must have 50% or greater improvement in both tender and swollen joints (28 tender and 28 swollen joints were assessed) and 50% 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 ESR or serum C-reactive protein (CRP) level.

  2. 28-joint count Disease Activity Score (DAS28)

    Time frame: Baselin and week 4

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

A Randomized Controlled Study to Determine the Effects and Safety of Topical Compound Tripterygium Wilfordii Hook F in Patients With Active Rheumatoid Arthritis.

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Oct 11, 2013
Registry last updated
Apr 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.