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Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis

Primary Purpose

Arthritis, Rheumatoid

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Topical tripterygium gel
Placebo gel
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 Arthritis, Rheumatoid focused on measuring Rheumatoid Arthritis, Tripterygium wilfordii Hook F, double-blinded, randomized controlled trial, Tripterygium, Administration, Topical

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.
  • 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.

Sites / Locations

  • Guang'anmen Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

topical TwHF gel group

placebo group

Arm Description

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 recipe composes viscous agent which matches by the sucrose. The usage and dosage of topical TwHF and placebo are the same.

Outcomes

Primary Outcome Measures

Twenty percent improvement in the American College of Rheumatology 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 erythrocyte sedimentation rate (ESR) or serum C-reactive protein (CRP) level.
Twenty percent improvement in the American College of Rheumatology criteria

Secondary Outcome Measures

Fifty percent improvement in the American College of Rheumatology 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 HAQ), and the ESR or CRP level.
The changes of the 28-joint count Disease Activity Score (DAS28)
The changes of Visual Analogue Scale (VAS) pain score
The change of knee synovitis classification as assessed by musculoskeletal ultrasound (MSUS)
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.
The change of knee synovial hyperplasia classification as assessed by MSUS
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.
The change of knee articular cavity effusion as assessed by MSUS
Articular cavity effusion adopts binary evaluation, namely: 0: normal, 1: abnormal.
The change of knee bone erosion classification as assessed by MSUS
Bone erosion classification adopts binary evaluation, namely: 0: normal, 1: abnormal.

Full Information

First Posted
June 15, 2016
Last Updated
November 19, 2018
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02818361
Brief Title
Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis
Official Title
Topical Tripterygium Wilfordii Gel for Treatment in Patients With Moderate Activity Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
December 2013 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Rheumatoid Arthritis, Tripterygium wilfordii Hook F, double-blinded, randomized controlled trial, Tripterygium, Administration, Topical

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
topical TwHF gel group
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo recipe composes viscous agent which matches by the sucrose. The usage and dosage of topical TwHF and placebo are the same.
Intervention Type
Drug
Intervention Name(s)
Topical tripterygium gel
Intervention Type
Drug
Intervention Name(s)
Placebo gel
Primary Outcome Measure Information:
Title
Twenty percent improvement in the American College of Rheumatology criteria
Description
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.
Time Frame
Week 8.
Title
Twenty percent improvement in the American College of Rheumatology criteria
Time Frame
Week 4.
Secondary Outcome Measure Information:
Title
Fifty percent improvement in the American College of Rheumatology criteria
Description
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.
Time Frame
Week 4 and week 8.
Title
The changes of the 28-joint count Disease Activity Score (DAS28)
Time Frame
Week 4 and week 8.
Title
The changes of Visual Analogue Scale (VAS) pain score
Time Frame
Week 1, 2, 3, 4, 5, 6, 7, and 8.
Title
The change of knee synovitis classification as assessed by musculoskeletal ultrasound (MSUS)
Description
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.
Time Frame
Week 2, 4, and 8.
Title
The change of knee synovial hyperplasia classification as assessed by MSUS
Description
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.
Time Frame
Week 2, 4, and 8.
Title
The change of knee articular cavity effusion as assessed by MSUS
Description
Articular cavity effusion adopts binary evaluation, namely: 0: normal, 1: abnormal.
Time Frame
Week 2, 4, and 8.
Title
The change of knee bone erosion classification as assessed by MSUS
Description
Bone erosion classification adopts binary evaluation, namely: 0: normal, 1: abnormal.
Time Frame
Week 2, 4, and 8.

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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quan Jiang, MD. PhD.
Organizational Affiliation
Rheumatology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guang'anmen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28870177
Citation
Jiang Q, Tang XP, Chen XC, Xiao H, Liu P, Jiao J. Will Chinese external therapy with compound Tripterygium wilfordii hook F gel safely control disease activity in patients with rheumatoid arthritis: design of a double-blinded randomized controlled trial. BMC Complement Altern Med. 2017 Sep 5;17(1):444. doi: 10.1186/s12906-017-1957-z.
Results Reference
derived

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Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis

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