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

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ClinicalTrials.gov Identifier: NCT02855658
Recruitment Status : Recruiting
First Posted : August 4, 2016
Last Update Posted : August 4, 2016
Sponsor:
Collaborators:
Chang Gung Memorial Hospital
China Medical University, China
National Research Program for Biopharmaceuticals, Taiwan
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sjögren's Syndrome Drug: SS-1 Drug: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome
Study Start Date : February 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Drug: SS-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.
Other Name: Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-Decoction

Placebo Comparator: 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.
Drug: 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.
Other Name: 1% SS-1




Primary Outcome Measures :
  1. Ocular surface disease index (OSDI) [ Time Frame: 7 months ]
    OSDI is an questionnaire of dry eye.

  2. EULAR Sjogren's syndrome patient reported index (ESSPRI) [ Time Frame: 7 months ]
    ESSPRI is an questionnaire of dry, pain and fatigue.

  3. Sjogren's syndrome symptoms Questionnaire [ Time Frame: 7 months ]
    Sjogren's syndrome symptoms Questionnaire is an questionnaire of dry month.

  4. Schirmer's test [ Time Frame: 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.

  5. Salivary scintigraphy [ Time Frame: 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.


Secondary Outcome Measures :
  1. Oxidative stress and antioxidant capacity [ Time Frame: 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

  2. Quality of life (SF-36) [ Time Frame: 7 months ]
  3. Regulatory effect on cytokine [ Time Frame: 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

  4. Nanostring nCounter immune Panel [ Time Frame: 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.


Other Outcome Measures:
  1. Adverse effect (AE) and Adverse drug reaction(ADR) [ Time Frame: 7 months ]
    Monitor the Adverse effect (AE) and Adverse drug reaction(ADR) during the SS-1 trial.

  2. Liver, Kidney and Blood function monitor [ Time Frame: 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).

  3. Traditional Chinese medicine (TCM) tongue diagnosis [ Time Frame: 7 months ]
    To evaluate the effect of the SS-1 on the TCM tongue diagnosis before and after treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855658


Contacts
Contact: Hen-Hong Chang, M.D., Ph.D. +886-3196200 ext 2677 tcmchh55@gmail.com
Contact: Ching-Mao Chang, M.D. +886-919074951 magicbjp@gmail.com

Locations
Taiwan
Taoyuan Chang Gung Memorial Hospital Recruiting
Gueishan Township, Taiwan, 333
Contact: Kuang-Hui Yu, M.D.       goutyu@gmail.com   
Principal Investigator: Shue-Fen Luo, M.D.         
Principal Investigator: Jr-Rung Lin, Ph.D.         
Principal Investigator: Yau-Huei Wei, Ph.D.         
Sub-Investigator: Ching-Mao Chang, M.D., Ph.D.         
Principal Investigator: Kuang-Hui Yu, M.D.         
China Medical University Hospital Recruiting
Taichung, Taiwan, 404
Contact: Hen-Hong Chang, M.D., Ph.D.    +886-4-22053366 ext 3501    tcmchh55@gmail.com   
Contact: Ching-Mao Chang, M.D.    886      
Principal Investigator: Hen-Hong Chang, M.D., Ph.D.         
Sponsors and Collaborators
China Medical University Hospital
Chang Gung Memorial Hospital
China Medical University, China
National Research Program for Biopharmaceuticals, Taiwan
Investigators
Study Chair: Hen-Hong Chang, M.D., Ph.D. China Medical University Hospital

Additional Information:
Publications of Results:
Responsible Party: China Medical University Hospital
ClinicalTrials.gov Identifier: NCT02855658     History of Changes
Other Study ID Numbers: CMUH105-REC3-025
First Posted: August 4, 2016    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by China Medical University Hospital:
Sjögren's syndrome
Gan-Lu-Yin
Sang-Ju-Yin
Xuefu-Zhuyu-Decoction
Oxidative stress
Immune regulation
Gene modulation
SS-1

Additional relevant MeSH terms:
Syndrome
Sjogren's Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases