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

Active Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01961505
• Other study ID #: Z111107058811104
• Status: Completed
• Phase: N/A
• First received: September 23, 2013
• Last updated: April 27, 2017
• Start date: October 2011
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Active Rheumatoid Arthritis
• Arthritis
• Arthritis, Rheumatoid

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR20 criteria	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.	Week 4
Secondary	ACR50 criteria	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.	Week 4
Secondary	28-joint count Disease Activity Score (DAS28)		Baselin and week 4