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Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02818361
Recruitment Status : Completed
First Posted : June 29, 2016
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Tracking Information
First Submitted Date  ICMJE June 15, 2016
First Posted Date  ICMJE June 29, 2016
Last Update Posted Date November 20, 2018
Actual Study Start Date  ICMJE April 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2016)
  • 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.
  • Twenty percent improvement in the American College of Rheumatology criteria [ Time Frame: Week 4. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2016)
  • 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.
  • The changes of the 28-joint count Disease Activity Score (DAS28) [ Time Frame: 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. ]
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Tripterygium Wilfordii Gel for Moderate Activity Rheumatoid Arthritis
Official Title  ICMJE Topical Tripterygium Wilfordii Gel for Treatment in Patients With Moderate Activity Rheumatoid Arthritis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Rheumatoid
Intervention  ICMJE
  • Drug: Topical tripterygium gel
  • Drug: Placebo gel
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Topical tripterygium gel
  • 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.
    Intervention: Drug: Placebo gel
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2018)
70
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2016)
168
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02818361
Other Study ID Numbers  ICMJE Z161100001816046
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Sponsor  ICMJE Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Quan Jiang, MD. PhD. Rheumatology Department
PRS Account Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP