Sjögren's SyndromePhase 2SS-1NCT02110446
Evaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's Syndrome
A Phase 2 study testing SS-1 in people with Sjögren's Syndrome, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
To evaluate the efficacy of Chinese herbal medicine (SS-1) for the Sjögren's syndrome (SJS) patients. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- 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
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2014to Jul 2016
- 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
- No healthy volunteers
- 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
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Center for Traditional Chinese Medicine, Taoyuan Chang Gung Memorial Hospital
Gueishan Township, Taoyuan, 333
Hen-Hong Chang, M.D., Ph.D., +886-3196200 ext. 2677, tcmchh55@gmail.com
Ching-Mao Chang, M.D.
About this study
Official title: Evaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's Syndrome - A Randomized Control Trial
To evaluate the efficacy of Chinese herbal medicine (SS-1) for the Sjögren's syndrome (SJS) patients.
Read the 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:
- SS-1 may improve the clinical manifestation and quality of life for the patients with Sjögren's syndrome
- To evaluate the effect of the Chinese medicine on the tongue diagnosis before and after treatment.
- 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).
- SS-1 may have the regulatory effect on cytokine secretion and immune function.
- 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.
- 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.
- Conditions
- Sjögren's Syndrome
- Being tested
- SS-1, Placebo
- Keywords
- Sjögren's syndrome, SS-1, Gan-Lu-Yin, Sang-Ju-Yin, Xuefu-Zhuyu-Decoction
- 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 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.
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)
SS-1 may improve the subjective observation of dry eye.
Measured: 7 months
EULAR Sjogren's syndrome patient reported index (ESSPRI)
SS-1 may improve the subjective sensation of dry, pain and fatigue.
Measured: 7 months
SJS symptoms Questionnaire
SS-1 may improve the subjective sensation of dry month.
Measured: 7 months
Schirmer's test
SS-1 may improve the objective observation of dry eye.
Measured: 7 months
Salivary scintigraphy
SS-1 may improve the objective observation of dry month.
Measured: 7 months
Secondary outcomes (3)
Oxidative stress and antioxidant capacity
SS-1 may reduce the oxidative stress and elevate the antioxidant capacity
Measured: 7 months
Quality of life (SF-36)
SS-1 may improve the subjective observation of quality of life.
Measured: 7 months
Regulatory effect on cytokine
SS-1 may have the regulatory effect on cytokine secretion and immune function.
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 posted10 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögren's SyndromeStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung University, National Science and Technology Council, Taiwan, China Medical University, China, China Medical University Hospital
- Responsible party
- Sponsor
- Investigators
- Hen-Hong Chang, M.D., Ph.D., Principal investigator, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110446
- Sponsor's protocol ID
- 102-2481A
- Acronym
- SS-1
- Status last verified
- Jan 2016
- First submitted
- 1 Apr 2014
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's Syndrome - A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02110446
- Acronym / sponsor ID
- SS-1 / 102-2481A
- Conditions
- Sjögren's Syndrome
- Keywords
- Sjögren's syndrome, SS-1, Gan-Lu-Yin, Sang-Ju-Yin, Xuefu-Zhuyu-Decoction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- Chang Gung University, National Science and Technology Council, Taiwan, China Medical University, China, China Medical University Hospital
- Study start
- Feb 2014
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 10 Apr 2014 (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 efficacy of Chinese herbal medicine (SS-1) for the Sjögren's syndrome (SJS) patients.
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:
- SS-1 may improve the clinical manifestation and quality of life for the patients with Sjögren's syndrome
- To evaluate the effect of the Chinese medicine on the tongue diagnosis before and after treatment.
- 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).
- SS-1 may have the regulatory effect on cytokine secretion and immune function.
- 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.
- 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.
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
- Not 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 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. | 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
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.
3 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- 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. principal investigator
Chang Gung University
1 site 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 Chang Gung Memorial Hospital at 1 site 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 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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 2 Feb 2016.