Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis

Topical Tripterygium Wilfordii Gel for Treatment in Patients With Moderate Activity Rheumatoid Arthritis

Tripterygium wilfordii Hook F (TwHF), a traditional Chinese herb, is widely used in China for treating Rheumatoid Arthritis (RA), but limited only for elderly RA patients because of its reproductive system toxicity. The investigators are inspired by Chinese external therapy, an immemorial therapy for thousands of years, and take its advantage to make TwHF topically in order to get an effective and safe treatment for active RA patients.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100053
        • Guang'anmen hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Documented diagnosis of rheumatoid arthritis, as defined by the American Rheumatism Association 1987 Revised Criteria.
  • Documented diagnosis of damp-heat syndrome according to Traditional Chinese Medicine.
  • Patients, men and women, must age from 18 to 65 years old.
  • Patients must have moderately active RA based on the criteria of the DAS-28 score from 3.2 to 5.1.
  • If patients are receiving Disease-modifying anti-rheumatic drugs (DMARDs), then the doses should have been kept stable for at least 12 weeks.
  • If patients are receiving non-steroidal anti-inflammatory drugs (NSAIDs) or orally Chinese herbal medicine, then the doses should have been kept stable for at least 4 weeks.

Exclusion Criteria:

  • Skin allergies or broken skin;
  • Taking TwHF agents, glucocorticoids and biological agents;
  • Female patients who are pregnant, breast-feeding or planed to be pregnant;
  • Subjects suffering serious hyperlipidemia, hyperglycemia, diabetes mellitus, cardiovascular diseases, gastrointestinal problems or liver and renal failure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: topical TwHF gel group
Topical TwHF gel recipe composes Tripterygium wilfordii Hook F, Mangxiao (Mirabilite), Chuanxiong (Rhizoma Ligustici), Ruxiang (Olibanum), Moyao (M yrrh) (prescription proportion is 4:4:2:2:1).Each gel is 20 gram(g). TwHF gel is applied for 1st to 5th metacarpophalangeal joints, 1st to 5th proximal interphalangeal joints, wrists, knees and ankles 20g for 1 hour, once per day from week 0 through week 4 and 10g for 1 hour, once per day from week 5 through week 8.
PLACEBO_COMPARATOR: placebo group
Placebo recipe composes viscous agent which matches by the sucrose. The usage and dosage of topical TwHF and placebo are the same.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Twenty percent improvement in the American College of Rheumatology criteria
Time Frame: Week 8.
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 erythrocyte sedimentation rate (ESR) or serum C-reactive protein (CRP) level.
Week 8.
Twenty percent improvement in the American College of Rheumatology criteria
Time Frame: Week 4.
Week 4.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fifty percent improvement in the American College of Rheumatology criteria
Time Frame: Week 4 and week 8.
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 HAQ), and the ESR or CRP level.
Week 4 and week 8.
The changes of the 28-joint count Disease Activity Score (DAS28)
Time Frame: Week 4 and week 8.
Week 4 and week 8.
The changes of Visual Analogue Scale (VAS) pain score
Time Frame: Week 1, 2, 3, 4, 5, 6, 7, and 8.
Week 1, 2, 3, 4, 5, 6, 7, and 8.
The change of knee synovitis classification as assessed by musculoskeletal ultrasound (MSUS)
Time Frame: Week 2, 4, and 8.
Synovitis classification is specific as follows: 0 level, no doppler signal; level 1: three independent point or 2 successive or 1 and 2 in independent dot doppler signal; level 2: doppler signal < 50% of the synovial membrane area; level 3 doppler signal is the synovium in > 50% of the area.
Week 2, 4, and 8.
The change of knee synovial hyperplasia classification as assessed by MSUS
Time Frame: Week 2, 4, and 8.
Synovial hyperplasia classification is specific as follows: 0 level, no synovial hyperplasia; level 1: synovial hyperplasia of mild, not more than bone surface high attachment; level 2: synovial hyperplasia more than bone surface high wire, but not more than the backbone; level 3: synovial hyperplasia more than bone surface peak wires, and extends along the backbone of the side.
Week 2, 4, and 8.
The change of knee articular cavity effusion as assessed by MSUS
Time Frame: Week 2, 4, and 8.
Articular cavity effusion adopts binary evaluation, namely: 0: normal, 1: abnormal.
Week 2, 4, and 8.
The change of knee bone erosion classification as assessed by MSUS
Time Frame: Week 2, 4, and 8.
Bone erosion classification adopts binary evaluation, namely: 0: normal, 1: abnormal.
Week 2, 4, and 8.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2012

Primary Completion (ACTUAL)

March 1, 2013

Study Completion (ACTUAL)

December 1, 2013

Study Registration Dates

First Submitted

June 15, 2016

First Submitted That Met QC Criteria

June 28, 2016

First Posted (ESTIMATE)

June 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

November 20, 2018

Last Update Submitted That Met QC Criteria

November 19, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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