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

Primary Purpose

Active Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Topical compound tripterygium
Placebo
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Active Rheumatoid Arthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Topical Tripterygium group

    Topical Placebo group

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    28-joint count Disease Activity Score (DAS28)

    Full Information

    First Posted
    September 23, 2013
    Last Updated
    April 27, 2017
    Sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01961505
    Brief Title
    Topical Compound Tripterygium Wilfordii Hook F for Patients With Active Rheumatoid Arthritis
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2011 (undefined)
    Primary Completion Date
    September 2015 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Active Rheumatoid Arthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Topical Tripterygium group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Topical Placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    Patients were treated with topical placebo for 1 hour, twice per day. The dosage was the same as the topical tripterygium group.
    Intervention Type
    Drug
    Intervention Name(s)
    Topical compound tripterygium
    Intervention Description
    Topical compound tripterygium was applied for the pain and swollen joints on non-woven fabric for 1 hour, twice per day.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    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 Measure Information:
    Title
    ACR20 criteria
    Description
    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.
    Time Frame
    Week 4
    Secondary Outcome Measure Information:
    Title
    ACR50 criteria
    Description
    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.
    Time Frame
    Week 4
    Title
    28-joint count Disease Activity Score (DAS28)
    Time Frame
    Baselin and week 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Quan Jiang
    Organizational Affiliation
    Guang'anmen Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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