Sjögren's SyndromePhase 2NCT02855658
Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome
A Phase 2 study testing SS-1 in people with Sjögren's Syndrome, run by China Medical University Hospital at 2 sites in Taiwan.
Trial summary
To evaluate the modulation of immunity-related gene expression for the Sjögren's syndrome under Chinese herbal medicine (SS-1) treatment. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sjögren's Syndrome
- What is being tested?
- SS-1
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesTaiwan
- Study dates
- Feb 2014to Apr 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Taoyuan Chang Gung Memorial Hospital
Gueishan Township, Taiwan, 333
Kuang-Hui Yu, M.D., goutyu@gmail.com
Shue-Fen Luo, M.D.
- Recruiting
China Medical University Hospital
Taichung, 404
Hen-Hong Chang, M.D., Ph.D., +886-4-22053366 ext. 3501, tcmchh55@gmail.com
Ching-Mao Chang, M.D., 886
About this study
To evaluate the modulation of immunity-related gene expression for the Sjögren's syndrome under Chinese herbal medicine (SS-1) treatment.
Read the 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:
- Establish the normal range of oxidative stress and cytokines for healthy control group.
- To evaluate the regulatory effect on oxidative stress and cytokine secretion between SS-1 group and healthy control group.
- To evaluate the immunity-related gene expression for the Sjögren's syndrome under the SS-1 treatment.
- To evaluate the immunity-related gene expression among the best efficacy SJS subjects and healthy control subjects.
- To evaluate the immunity-related gene expression with the characteristic of TCM tongue diagnosis.
- To analyze the correlation among clinical manifestations, Sjögren's syndrome -related clinical questionnaires and immunity-related gene expression.
- Conditions
- Sjögren's Syndrome
- Being tested
- SS-1, Placebo
- Keywords
- Sjögren's syndrome, Gan-Lu-Yin, Sang-Ju-Yin, Xuefu-Zhuyu-Decoction, Oxidative stress, Immune regulation, Gene modulation, SS-1
- Medical subject headings
- Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SS-1Drug
Also called Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-Decoction
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.
PlaceboDrug
Also called 1% SS-1
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.
| Study group | Role | What they receive |
|---|---|---|
| SS-1 | Experimental | 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. Receives: Drug: SS-1 |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular surface disease index (OSDI)
OSDI is an questionnaire of dry eye.
Measured: 7 months
EULAR Sjogren's syndrome patient reported index (ESSPRI)
ESSPRI is an questionnaire of dry, pain and fatigue.
Measured: 7 months
Sjogren's syndrome symptoms Questionnaire
Sjogren's syndrome symptoms Questionnaire is an questionnaire of dry month.
Measured: 7 months
Schirmer's test
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.
Measured: 7 months
Salivary scintigraphy
Salivary scintigraphy is an objective detection of dry month, which is used to detect the salivary flow in parotid gland of Sjogren's syndrome.
Measured: 7 months
Secondary outcomes (4)
Oxidative stress and antioxidant capacity
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
Measured: 7 months
Quality of life (SF-36)
Measured: 7 months
Regulatory effect on cytokine
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
Measured: 7 months
Nanostring nCounter immune Panel
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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startFeb 2014
- Primary completionOct 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, China Medical University, China, National Research Program for Biopharmaceuticals, Taiwan
- Responsible party
- Sponsor
- Investigators
- Hen-Hong Chang, M.D., Ph.D., Study chair, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855658
- Sponsor's protocol ID
- CMUH105-REC3-025
- Status last verified
- Aug 2016
- First submitted
- 13 Jul 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Chang CM, Chu HT, Wei YH, Chen FP, Wang S, Wu PC, Yen HR, Chen TJ, Chang HH. The Core Pattern Analysis on Chinese Herbal Medicine for Sjogren's syndrome: A Nationwide Population-Based Study. Sci Rep. 2015 Apr 29;5:9541. doi: 10.1038/srep09541.
PubMed 25923413
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT02855658
- Acronym / sponsor ID
- CMUH105-REC3-025
- Conditions
- Sjögren's Syndrome
- Keywords
- Sjögren's syndrome, Gan-Lu-Yin, Sang-Ju-Yin, Xuefu-Zhuyu-Decoction, Oxidative stress, Immune regulation, Gene modulation, SS-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, China Medical University, China, National Research Program for Biopharmaceuticals, Taiwan
- Study start
- Feb 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Establish the normal range of oxidative stress and cytokines for healthy control group.
- To evaluate the regulatory effect on oxidative stress and cytokine secretion between SS-1 group and healthy control group.
- To evaluate the immunity-related gene expression for the Sjögren's syndrome under the SS-1 treatment.
- To evaluate the immunity-related gene expression among the best efficacy SJS subjects and healthy control subjects.
- To evaluate the immunity-related gene expression with the characteristic of TCM tongue diagnosis.
- To analyze the correlation among clinical manifestations, Sjögren's syndrome -related clinical questionnaires and immunity-related gene expression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SS-1 | Experimental | Drug: SS-1SS-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. |
| Placebo | Placebo comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SS-1Also: Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-DecoctionThe 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. | Drug | SS-1 |
| PlaceboAlso: 1% SS-1The 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 |
Primary outcome
Ocular surface disease index (OSDI)
Time frame: 7 months
OSDI is an questionnaire of dry eye.
EULAR Sjogren's syndrome patient reported index (ESSPRI)
Time frame: 7 months
ESSPRI is an questionnaire of dry, pain and fatigue.
Sjogren's syndrome symptoms Questionnaire
Time frame: 7 months
Sjogren's syndrome symptoms Questionnaire is an questionnaire of dry month.
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.
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.
4 secondary outcomes
Oxidative stress and antioxidant capacity
Time frame: 7 months
Quality of life (SF-36)
Time frame: 7 months
Regulatory effect on cytokine
Time frame: 7 months
Nanostring nCounter immune Panel
Time frame: 7 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Results publication: PubMed 25923413Chang CM, Chu HT, Wei YH, Chen FP, Wang S, Wu PC, Yen HR, Chen TJ, Chang HH. The Core Pattern Analysis on Chinese Herbal Medicine for Sjogren's syndrome: A Nationwide Population-Based Study. Sci Rep. 2015 Apr 29;5:9541. doi: 10.1038/srep09541.
- NCT02110446: Evaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's Syndrome (SS-1)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hen-Hong Chang, M.D., Ph.D. study chair
China Medical University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SS-1 in people with Sjögren's Syndrome, run by China Medical University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hen-Hong Chang, M.D., Ph.D. (+886-3196200 ext. 2677, tcmchh55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular surface disease index (OSDI) (time frame: 7 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02855658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.