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

NCT01961505 | Completed

• 1 other identifier: Z111107058811104
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Active Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• ACR50 criteria

  Week 4

• 28-joint count Disease Activity Score (DAS28)

  Baselin and week 4

Study Arms (2)

Topical Tripterygium group

EXPERIMENTAL

Patients were treated with topical compound tripterygium for 1 hour, twice per day. Area dosages were as followed that each 1st to 5th metacarpophalangeal joints (MCPJs), 1st to 5th proximal interphalangeal joints (PIPJs) and wrist was 3 ml, each elbow and ankle was 5 ml, each knee was 10 ml.

Drug: Topical compound tripterygium

Topical Placebo group

PLACEBO COMPARATOR

Patients were treated with topical placebo for 1 hour, twice per day. The dosage was the same as the topical tripterygium group.

Drug: Placebo

Interventions

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.

Topical Tripterygium group

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.

Topical 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 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.
• to 65 years old, having signed the informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Officials

• Quan Jiang

  Guang'anmen Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: October 11, 2013
• Study Start: October 1, 2011
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2016
• Last Updated: April 28, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share