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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Brief Summary:
To investigate the efficacy and safety of traditional Chinese medicine in patients with Sjogren's syndrome.

Condition or disease Intervention/treatment Phase
Sjögren's Syndrome Drug: TCM (Gan-Lu-Yin)GLY Drug: PLACEBO Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: A Double Blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.
Actual Study Start Date : May 6, 2016
Actual Primary Completion Date : October 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

Placebo Comparator: PLACEBO
TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks
Drug: PLACEBO
TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT04111341


Locations
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Taiwan
Chung Shan Medical University Hospital
Taichung, Taiwan, 402
Sponsors and Collaborators
Chung Shan Medical University
Investigators
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Principal Investigator: Wei C- C, M Chung Shan Medical University
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Responsible Party: Cheng-Chung Wei, Professor, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT04111341    
Other Study ID Numbers: CS16051
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cheng-Chung Wei, Chung Shan Medical University:
Sjögren's syndrome
Traditional Chinese Medicine
Herbs
Clinical trial
Gan-Lu-Yin
Jia-wei-Xiao-yao-San
Ye-Jiao-Teng
Suan-Zao-Ren
Additional relevant MeSH terms:
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Sjogren's Syndrome
Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases