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A Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.

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ClinicalTrials.gov Identifier: NCT04111341
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Cheng-Chung Wei, Chung Shan Medical University

Tracking Information
First Submitted Date  ICMJE September 26, 2019
First Posted Date  ICMJE October 1, 2019
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE May 6, 2016
Actual Primary Completion Date October 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
Change from baseline EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at week 12 [ Time Frame: week 0, week 12 ]
The investigators use ESSPRI to compared the difference between the week 12 and 0
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2019)
  • Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 4 [ Time Frame: week 0, week 4 ]
    The investigators use ESSDAI to compared the difference between the the week 4 and 0
  • Physicians Global Assessment to measure quality of life (PGA) [ Time Frame: week 0, week 4, week 8, week 12 ]
    The investigators use PGA to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0
  • Visual Analog Scale for pain (VAS) [ Time Frame: week 0, week 4, week 8, week 12 ]
    The investigators use VAS to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0
  • Quality of life by SF-36 [ Time Frame: week 0, week 4, week 8, week 12 ]
    The investigators use SF-36 to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0
  • modified fatigue impact scale (MFI) [ Time Frame: week 0, week 4, week 8, week 12 ]
    The investigators use MFI to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0
  • Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: week 0, week 4, week 8, week 12 ]
    The investigators use PSQI to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0
  • Body Constitution Questionnaire (BCQ) [ Time Frame: week 0, week 4, week 8, week 12 ]
    The investigators use BCQ to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0
  • Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 8 [ Time Frame: week 0, week 8 ]
    The investigators use ESSDAI to compared the difference between the week 8 and 0
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 A Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.
Official Title  ICMJE A Double Blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.
Brief Summary To investigate the efficacy and safety of traditional Chinese medicine in patients with Sjogren's syndrome.
Detailed Description This is 2 years' double blind, randomized, placebo-controlled clinical trial. Patients fulfilled the classification criteria of Sjogren syndrome will be recruited. Eligible subjects will be randomized on a 2:1 ratio to Traditional Chinese Medicine (TCM) granules or placebo for 12 weeks. The treatment group will receive a combination formula with traditional Chinese medicine, Gan-Lu-Yin in the morning and Jia-wei-Xiao-yao-San in the evening. Primary endpoint is the ESSPRI, European Sjogren Syndrome Patient Reported Outcome Index. Secondary endpoints include disease activity index (ESSDAI) , patient global assessment (PGA), VAS pain scale, Quality of Life by Short Form-36 (SF-36), fatigue scale and related serological markers. Thirty patients will be enrolled in the first year. After interim analysis at the end of first year, sample size will be recalculated base on the interim analysis results.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Sjögren's Syndrome
Intervention  ICMJE
  • Drug: TCM (Gan-Lu-Yin)GLY
    TCM Gan-Lu-Yin 6g in the morning TCM Jia-Wei-Xiao-Yao-San, Ye-Jiao-Teng, Suan-Zao-Ren 8g in the evening for 12 weeks
    Other Name: Gan-Lu-Yin
  • Drug: PLACEBO
    TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks
Study Arms  ICMJE
  • Experimental: TCM Gan-Lu-Yin (GLY)
    TCM Gan-Lu-Yin 6g in the morning TCM Jia-Wei-Xiao-Yao-San, Ye-Jiao-Teng, Suan-Zao-Ren 8g in the evening for 12 weeks
    Intervention: Drug: TCM (Gan-Lu-Yin)GLY
  • Placebo Comparator: PLACEBO
    TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks
    Intervention: Drug: PLACEBO
Publications * Not Provided

*   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: September 30, 2019)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date October 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥20 years old
  • Written informed consent obtained
  • Been diagnosed with the diagnostic criteria for Sjogren's syndrome (according to the 2002 European Classification Standard)
  • The ESSPRI score of the patient of Sjogren's syndrome at least> 3

Exclusion Criteria:

  • Have association disease about heart, lung, nerve or mental
  • Pregnant or breastfeeding women
  • Laboratory abnormality:

    1. Serum creatinine ≥2.0 mg/dl
    2. Male: Hb≤9 g/dl;Female: Hb≤8.5 g/dl
    3. Neutrophil or lymphocyte<0.5 x 109/l
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 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 Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04111341
Other Study ID Numbers  ICMJE CS16051
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Cheng-Chung Wei, Chung Shan Medical University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Chung Shan Medical University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wei C- C, M Chung Shan Medical University
PRS Account Chung Shan Medical University
Verification Date September 2019

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