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

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

Detailed Description
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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.

Official Title
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A Double Blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.

Conditions
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Sjögren's Syndrome

Intervention / Treatment
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* Drug: TCM (Gan-Lu-Yin)GLY
* Drug: PLACEBO


Participation Criteria
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Eligibility Criteria
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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: Serum creatinine ≥2.0 mg/dl Male: Hb≤9 g/dl;Female: Hb≤8.5 g/dl Neutrophil or lymphocyte<0.5 x 109/l

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCM Gan-Lu-Yin (GLY)<br>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<br>* 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<br>* Other names: Gan-Lu-Yin;|
| Placebo Comparator: PLACEBO<br>TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks | Drug: PLACEBO<br>* TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at week 12 | The investigators use ESSPRI to compared the difference between the week 12 and 0 | week 0, week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 4 | The investigators use ESSDAI to compared the difference between the the week 4 and 0 | week 0, week 4 | 
| Physicians Global Assessment to measure quality of life (PGA) | The investigators use PGA to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0 | week 0, week 4, week 8, week 12 | 
| Visual Analog Scale for pain (VAS) | The investigators use VAS to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0 | week 0, week 4, week 8, week 12 | 
| Quality of life by SF-36 | 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 | week 0, week 4, week 8, week 12 | 
| modified fatigue impact scale (MFI) | The investigators use MFI to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0 | week 0, week 4, week 8, week 12 | 
| Pittsburgh Sleep Quality Index (PSQI) | The investigators use PSQI to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0 | week 0, week 4, week 8, week 12 | 
| Body Constitution Questionnaire (BCQ) | The investigators use BCQ to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0 | week 0, week 4, week 8, week 12 | 
| Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 8 | The investigators use ESSDAI to compared the difference between the week 8 and 0 | week 0, week 8 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sjögren's syndrome, Traditional Chinese Medicine, Herbs, Clinical trial, Gan-Lu-Yin, Jia-wei-Xiao-yao-San, Ye-Jiao-Teng, Suan-Zao-Ren