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

China Medical University

Status and phase: Unknown; Phase 2

Conditions: Sjögren's Syndrome

Treatments: Drug: SS-1; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02855658

CMUH105-REC3-025

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

SS-1

Experimental group

Description:

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.

Treatment:

Drug: SS-1

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo