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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01961505
Recruitment Status : Completed
First Posted : October 11, 2013
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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).

Condition or disease Intervention/treatment Phase
Active Rheumatoid Arthritis Drug: Topical compound tripterygium Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : October 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Topical Tripterygium group
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 compound tripterygium was applied for the pain and swollen joints on non-woven fabric for 1 hour, twice per day.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961505


Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
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Principal Investigator: Quan Jiang Guang'anmen Hospital
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Responsible Party: Quan Jiang, director, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT01961505    
Other Study ID Numbers: Z111107058811104
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases