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

Chung Shan Medical University30 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Sjögren's Syndrome

Interventions

TCM (Gan-Lu-Yin)GLYDRUG

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

PLACEBODRUG

TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Chung Shan Medical University Hospital

Taichung, Taiwan

Outcomes

Primary Outcomes

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

Time frame: week 0, week 12

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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