To evaluate the modulation of immunity-related gene expression for the Sjögren's syndrome under Chinese herbal medicine (SS-1) treatment.
Objective: To evaluate the modulation of immunity-related gene expression for the Sjögren's syndrome under Chinese herbal medicine (SS-1) treatment. Method: The evidence of the regulation of oxidative-related cytokines and the antioxidant capacity could be provided from the previous randomized, double-blinded, placebo-controlled, cross-over design, two-center clinical trial for evaluating the effect of Chinese herbal medicine (SS-1) for the Sjögren's syndrome patients. However, the clinical trail could not find out the modulation of immunity-related gene expression for SS-1 treatment, and it did set up a healthy control group for SS-1 comparison. This study want to establish a healthy control group for evaluating the normal range of oxidative stress and cytokines, which this work could be used to compare with the 72 SS-1 subjects in previous study. And This study also want to analyze the 770 immunity-related gene expression for the Sjögren's syndrome under the SS-1 treatment: (1) The best 20 (at least) efficacy SJS subjects who were evaluated before and after SS-1 treatments. (2) The 10 (at least) healthy control subjects. The findings could provide the evidence on the modulation of immunity-related gene expression for clinical manifestation, oxidative stress and cytokine in Sjögren's syndrome patients. Expected Results: 1. Establish the normal range of oxidative stress and cytokines for healthy control group. 2. To evaluate the regulatory effect on oxidative stress and cytokine secretion between SS-1 group and healthy control group. 3. To evaluate the immunity-related gene expression for the Sjögren's syndrome under the SS-1 treatment. 4. To evaluate the immunity-related gene expression among the best efficacy SJS subjects and healthy control subjects. 5. To evaluate the immunity-related gene expression with the characteristic of TCM tongue diagnosis. 6. To analyze the correlation among clinical manifestations, Sjögren's syndrome -related clinical questionnaires and immunity-related gene expression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
The patients will be divided into two groups (A and B) at random and all of them keep the routine treatment in the rheumatology OPD. Group A patients will receive 12 weeks SS-1 treatment first, and then stop the SS-1 for 4 weeks for wash-out phase, and then receive 12 weeks placebo treatment. Group B patients receive 12 weeks placebo first, and then stop the placebo treatment for 4 weeks for wash-out phase, and then receive 12 weeks SS-1 treatment. SS-1 is composed of 3 traditional Chinese herbal formula: Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-Decoction with the ratio of 2:1:1. The placebo is composed with corn starch, pigment and minimal dose of 1% SS-1. Patients in both groups take 6 gram of SS-1/Placebo three times per day.
The placebo is composed of corn starch, pigment and minimal dose of 1% SS-1. Patients take 6 gram of experiment medicine three times per day.
Taoyuan Chang Gung Memorial Hospital
Gueishan Township, Taiwan, Taiwan
RECRUITINGChina Medical University Hospital
Taichung, Taiwan
RECRUITINGOcular surface disease index (OSDI)
OSDI is an questionnaire of dry eye.
Time frame: 7 months
EULAR Sjogren's syndrome patient reported index (ESSPRI)
ESSPRI is an questionnaire of dry, pain and fatigue.
Time frame: 7 months
Sjogren's syndrome symptoms Questionnaire
Sjogren's syndrome symptoms Questionnaire is an questionnaire of dry month.
Time frame: 7 months
Schirmer's test
Schirmer's test is an objective detection of dry eye, which this test use paper strips inserted into the eye for 5 minutes to measure the production of tears.
Time frame: 7 months
Salivary scintigraphy
Salivary scintigraphy is an objective detection of dry month, which is used to detect the salivary flow in parotid gland of Sjogren's syndrome.
Time frame: 7 months
Oxidative stress and antioxidant capacity
To evaluate the effect of the SS-1 on the oxidative stress and antioxidant capacity. The "relative ratio" is the unit of these biomarkers for oxidative stress and antioxidant capacity
Time frame: 7 months
Quality of life (SF-36)
Time frame: 7 months
Regulatory effect on cytokine
To evaluate the effect of the SS-1 on the cytokine. The "pg/ml" is the unit of these biomarkers for oxidative stress and antioxidant capacity
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Time frame: 7 months
Nanostring nCounter immune Panel
To evaluate the effect of the SS-1 on the immunity-related gene expression. Nanostring nCounter immune Panel is a tool for detecting the immunity-related gene expression.
Time frame: 7 months