Sjögren's Syndrome Clinical Trial
Official title:
Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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