Clinical trial NCT02855658: Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome
Official title: Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sjögren's Syndrome
Keywords: Sjögren's syndrome
Gan-Lu-Yin
Sang-Ju-Yin
Xuefu-Zhuyu-Decoction
Oxidative stress
Immune regulation
Gene modulation
SS-1
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Chang Gung Memorial Hospital
name: China Medical University, China
name: National Research Program for Biopharmaceuticals, Taiwan
First posted: 2016-08-04
Enrollment: 90
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the modulation of immunity-related gene expression for the Sjögren's syndrome under Chinese herbal medicine (SS-1) treatment.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Primary or Secondary Sjögren's syndrome patient
* Age from 20 to 75 year old, male or female patient
* Fit the criteria of 2002 year American-European classification
* If the subject took Cyclosporine, Cevimeline, Pilocarpine, Rituximab or other biological agent before enter into our study, the subject need to stop these drugs for one month
* If the subject took Gan-Lu-Yin, Sang- Ju-Yin or Xuefu-Zhuyu-Decoction before enter into our study, the subject need to stop these drugs for one month
* Secondary Sjögren's syndrome patient:

  * Stable treatment: Steroid (≦10mg/d) and fixed hydroxychloroquine dose before 3 months enrolled
  * No abnormal change of immunology, liver, kidney, and blood function
  * No major life threatened condition

Exclusion Criteria:

* Alcohol abuse, DM (Glucose PC\>200mg/dL) and major life threatened condition
* Pregnancy or breast feeding
* Abnormal liver and kidney function
* Forbid steroid pulse therapy before 3 months enrolled into our study, and forbid the Chinese herbal medicine except SS-1

Primary outcomes:
measure: Ocular surface disease index (OSDI)
timeFrame: 7 months
measure: EULAR Sjogren's syndrome patient reported index (ESSPRI)
timeFrame: 7 months
measure: Sjogren's syndrome symptoms Questionnaire
timeFrame: 7 months
measure: Schirmer's test
timeFrame: 7 months
measure: Salivary scintigraphy
timeFrame: 7 months
Secondary outcomes:
measure: Oxidative stress and antioxidant capacity
timeFrame: 7 months
measure: Quality of life (SF-36)
timeFrame: 7 months
measure: Regulatory effect on cytokine
timeFrame: 7 months
measure: Nanostring nCounter immune Panel
timeFrame: 7 months
Other outcomes:
measure: Adverse effect (AE) and Adverse drug reaction(ADR)
timeFrame: 7 months
measure: Liver, Kidney and Blood function monitor
timeFrame: 7 months
measure: Traditional Chinese medicine (TCM) tongue diagnosis
timeFrame: 7 months
Locations:
city: Gueishan Township
country: Taiwan
facility: Taoyuan Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University Hospital
name: Hen-Hong Chang, M.D., Ph.D.
role: STUDY_CHAIR
References:
citation: Chang CM, Chu HT, Wei YH, Chen FP, Wang S, Wu PC, Yen HR, Chen TJ, Chang HH. The Core Pattern Analysis on Chinese Herbal Medicine for Sjogren's syndrome: A Nationwide Population-Based Study. Sci Rep. 2015 Apr 29;5:9541. doi: 10.1038/srep09541.