Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome

Phase 2

• Conditions: Sjögren's Syndrome
• Interventions: Drug: Placebo; Drug: SS-1

• Registration Number: NCT02855658
• Lead Sponsor: China Medical University Hospital

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.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2016-07-13
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-01
• Last Update Submitted: 2016-08-01
• Study First Posted: 2016-08-04
• Last Update Posted: 2016-08-04
• Primary Completion: 2016-10
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	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.
SS-1	SS-1	SS-1 is composed of the powder of Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-Decoction with the ratio of 2:1:1. Patients take 6 gram of experiment medicine three times per day.

Primary Outcome Measures

Name	Time	Method
Salivary scintigraphy	7 months	Salivary scintigraphy is an objective detection of dry month, which is used to detect the salivary flow in parotid gland of Sjogren's syndrome.
EULAR Sjogren's syndrome patient reported index (ESSPRI)	7 months	ESSPRI is an questionnaire of dry, pain and fatigue.
Ocular surface disease index (OSDI)	7 months	OSDI is an questionnaire of dry eye.
Sjogren's syndrome symptoms Questionnaire	7 months	Sjogren's syndrome symptoms Questionnaire is an questionnaire of dry month.
Schirmer's test	7 months	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.

Secondary Outcome Measures

Name	Time	Method
Oxidative stress and antioxidant capacity	7 months	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
Regulatory effect on cytokine	7 months	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
Nanostring nCounter immune Panel	7 months	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.
Quality of life (SF-36)	7 months

Trial Locations

Locations (2)

Taoyuan Chang Gung Memorial Hospital; 🇨🇳 Gueishan Township, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan