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Trial record 5 of 6 for:    olibanum

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

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Topical Tripterygium Wilfordii Gel for Treatment in Patients With Moderate Activity Rheumatoid Arthritis
Actual Study Start Date : April 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : December 2013

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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.
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.
Drug: Placebo gel



Primary Outcome Measures :
  1. 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.

  2. Twenty percent improvement in the American College of Rheumatology criteria [ Time Frame: Week 4. ]

Secondary Outcome Measures :
  1. 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.

  2. The changes of the 28-joint count Disease Activity Score (DAS28) [ Time Frame: Week 4 and week 8. ]
  3. The changes of Visual Analogue Scale (VAS) pain score [ Time Frame: Week 1, 2, 3, 4, 5, 6, 7, and 8. ]
  4. 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.

  5. 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.

  6. 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.

  7. 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.



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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.
  • 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.

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): NCT02818361


Locations
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China, Beijing
Guang'anmen Hospital
Beijing, Beijing, China, 100053
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Investigators
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Principal Investigator: Quan Jiang, MD. PhD. Rheumatology Department

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Quan Jiang, Chief, Rheumatology Department, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02818361     History of Changes
Other Study ID Numbers: Z161100001816046
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Rheumatoid Arthritis
Tripterygium wilfordii Hook F
double-blinded
randomized controlled trial
Tripterygium
Administration
Topical

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