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

Study Description

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Taiwan

Chung Shan Medical University Hospital

Taichung, Taiwan, 402

Sponsors and Collaborators

Chung Shan Medical University

Investigators

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

More Information

• Responsible Party: Cheng-Chung Wei, Professor, Chung Shan Medical University
• ClinicalTrials.gov Identifier: NCT04111341
• Other Study ID Numbers: CS16051
• First Posted: October 1, 2019
• 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:

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