Sjögren's Syndrome
Conditions
Keywords
Sjögren's syndrome, Gan-Lu-Yin, Sang-Ju-Yin, Xuefu-Zhuyu-Decoction, Oxidative stress, Immune regulation, Gene modulation, SS-1
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.
Interventions
DRUGSS-1
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.
DRUGPlacebo
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.
Sponsors
Chang Gung Memorial Hospital
China Medical University, China
National Research Program for Biopharmaceuticals, Taiwan
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Sjogren's syndrome symptoms Questionnaire | 7 months | Sjogren's syndrome symptoms Questionnaire is an questionnaire of dry month. |
| Ocular surface disease index (OSDI) | 7 months | OSDI is an questionnaire of dry eye. |
| EULAR Sjogren's syndrome patient reported index (ESSPRI) | 7 months | ESSPRI is an questionnaire of dry, pain and fatigue. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| Quality of life (SF-36) | 7 months | — |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse effect (AE) and Adverse drug reaction(ADR) | 7 months | Monitor the Adverse effect (AE) and Adverse drug reaction(ADR) during the SS-1 trial. |
| Traditional Chinese medicine (TCM) tongue diagnosis | 7 months | To evaluate the effect of the SS-1 on the TCM tongue diagnosis before and after treatment. |
| Liver, Kidney and Blood function monitor | 7 months | Monitor the Liver, Kidney and Blood function monitor (RBC, WBC, Hb, Platelet, AST, ALT, BUN, Cre) of patient during the SS-1 trial, and the different units are listed below: WBC (1000/uL), RBC (million/uL), Hb (g/dL), Platelet (1000/uL), AST (U/L), ALT (U/L), BUN (mg/dL), Serum Creatinine (mg/dL). |
Countries
Taiwan
Contacts
Primary ContactHen-Hong Chang, M.D., Ph.D.
Backup ContactChing-Mao Chang, M.D.
Outcome results
None listed