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

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

Tracking Information

• First Submitted Date: September 26, 2019
• First Posted Date: October 1, 2019
• Last Update Posted Date: October 1, 2019
• Actual Study Start Date: May 6, 2016
• Actual Primary Completion Date: October 31, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Basic Science
• Condition: Sjögren's Syndrome

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 30, 2019): 30
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 31, 2017
• Actual Primary Completion Date: October 31, 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Taiwan

Administrative Information

• NCT Number: NCT04111341
• Other Study ID Numbers: CS16051
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Cheng-Chung Wei, Chung Shan Medical University
• Original Responsible Party: Same as current
• Current Study Sponsor: Chung Shan Medical University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Wei C- C, M; Chung Shan Medical University

• PRS Account: Chung Shan Medical University
• Verification Date: September 2019