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Evaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's Syndrome (SS-1)

This study is currently recruiting participants.
Verified January 2016 by Chang Gung Memorial Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02110446
First Posted: April 10, 2014
Last Update Posted: February 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Chang Gung University
National Science Council, Taiwan
China Medical University, China
China Medical University Hospital
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
  Purpose
To evaluate the efficacy of Chinese herbal medicine (SS-1) for the Sjögren's syndrome (SJS) patients.

Condition Intervention Phase
Sjögren's Syndrome Drug: SS-1 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's Syndrome - A Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • Ocular surface disease index (OSDI) [ Time Frame: 7 months ]
    SS-1 may improve the subjective observation of dry eye.

  • EULAR Sjogren's syndrome patient reported index (ESSPRI) [ Time Frame: 7 months ]
    SS-1 may improve the subjective sensation of dry, pain and fatigue.

  • SJS symptoms Questionnaire [ Time Frame: 7 months ]
    SS-1 may improve the subjective sensation of dry month.

  • Schirmer's test [ Time Frame: 7 months ]
    SS-1 may improve the objective observation of dry eye.

  • Salivary scintigraphy [ Time Frame: 7 months ]
    SS-1 may improve the objective observation of dry month.


Secondary Outcome Measures:
  • Oxidative stress and antioxidant capacity [ Time Frame: 7 months ]
    SS-1 may reduce the oxidative stress and elevate the antioxidant capacity

  • Quality of life (SF-36) [ Time Frame: 7 months ]
    SS-1 may improve the subjective observation of quality of life.

  • Regulatory effect on cytokine [ Time Frame: 7 months ]
    SS-1 may have the regulatory effect on cytokine secretion and immune function.


Other Outcome Measures:
  • 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.

  • Liver, Kidney and Blood function monitor [ Time Frame: 7 months ]
    Monitor the Liver, Kidney and Blood function (RBC, WBC, Hb, PLT, AST, ALT, BUN, Cre) of patient during the SS-1 trial.

  • 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.


Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 12weeks 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 12weeks 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

Detailed Description:

Investigators take a randomized, double-blinded, placebo-controlled, cross-over design clinical trial to evaluate the effect of Chinese herbal medicine (SS-1) on the regulation of oxidative-related cytokines and the antioxidant capacity for the Sjögren's syndrome (SJS) patients. Through the oxidative stress reduction, the quality of life and clinical manifestation will be improved. Investigators will also use a SJS cell model to elucidate the antioxidant mechanism of SS-1.

The SJS patients in this clinical trial will be screened and be referred from the out-patient department (OPD) of the Rheumatology Department of Chang Gung Memorial Hospital. 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 stop the SS-1 for 4 weeks to enter the wash-out phase, and then receive 12 weeks placebo treatment after the wash-out phase. Group B patients receive 12 weeks placebo first and stop the placebo treatment for 4 weeks to enter the wash-out phase, and then receive 12 weeks SS-1 treatment after the wash-out phase. 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 and the placebo is composed with corn starch, pigment and 1/100 SS-1. Patients in both groups take 6 gram of experiment medicine three times per day. Investigators plan to evaluate the associated parameters at the time just before treatment (V1), after treatment for 12 weeks (V2), at the end of wash-out phase (V3) and when the crossover treatment is completed (V4). Investigators use EULAR Sjogren's syndrome patient reported index, ocular surface disease index and SJS symptom questionnaire for clinical evaluation, and use the SF-36 for quality of life. And investigators use the schirmer's test, salivary scintigraphy, oxidative stress marker and related cytokine for objective observation.

Expected Results:

  1. SS-1 may improve the clinical manifestation and quality of life for the patients with Sjögren's syndrome
  2. To evaluate the effect of the Chinese medicine on the tongue diagnosis before and after treatment.
  3. SS-1 may reduce the oxidative stress (8-OHdG and mtDNA 4977 bp deletion) and elevate the antioxidant capacity (TAC, GSH, mtDNA copy number, SOD, GPX, CAT).
  4. SS-1 may have the regulatory effect on cytokine secretion and immune function.
  5. SS-1 may have the capacity of reducing the oxidative stress, elevating the antioxidant capacity and regulating the immune response in the model of submaxillary salivary gland cell line with the induction of IFN-γand IFN-α.
  6. Identification of the single herb in the SS-1 mixture that regulates oxidative stress and cytokine in the model of submaxillary salivary gland cell line, and set up of the Chinese herbs screen platform for Sjögren's syndrome.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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): NCT02110446


Contacts
Contact: Hen-Hong Chang, M.D., Ph.D. +886-3196200 ext 2677 tcmchh55@gmail.com
Contact: Ching-Mao Chang, M.D. +886-3196200 ext 2676 magicbjp@gmail.com

Locations
Taiwan
Center for Traditional Chinese Medicine, Taoyuan Chang Gung Memorial Hospital Recruiting
Gueishan Township, Taoyuan, Taiwan, 333
Contact: Hen-Hong Chang, M.D., Ph.D.    +886-3196200 ext 2677    tcmchh55@gmail.com   
Sub-Investigator: Ching-Mao Chang, M.D.         
Principal Investigator: Yau-Huei Wei, Ph.D.         
Principal Investigator: Jr-Rung Lin, Ph.D.         
Principal Investigator: Kuang-Hui Yu, M.D.         
Principal Investigator: Shue-Fen Luo, M.D.         
Principal Investigator: Hen-Hong Chang, M.D.         
Principal Investigator: Yeong-Jian Jan Wu Jan, M.D.         
Principal Investigator: Ji-Yih Chen, M.D.         
Principal Investigator: Yao-Fan Fang, M.D.         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Chang Gung University
National Science Council, Taiwan
China Medical University, China
China Medical University Hospital
Investigators
Principal Investigator: Hen-Hong Chang, M.D., Ph.D. Chang Gung University
  More Information

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02110446     History of Changes
Other Study ID Numbers: 102-2481A
First Submitted: April 1, 2014
First Posted: April 10, 2014
Last Update Posted: February 2, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chang Gung Memorial Hospital:
Sjögren's syndrome
SS-1
Gan-Lu-Yin
Sang-Ju-Yin
Xuefu-Zhuyu-Decoction

Additional relevant MeSH terms:
Sjogren's Syndrome
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