Sjögren's SyndromePhase 2NCT04111341
A Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.
A Phase 2 study testing TCM (Gan-Lu-Yin)GLY in people with Sjögren's Syndrome, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
To investigate the efficacy and safety of traditional Chinese medicine in patients with Sjogren's syndrome. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Sjögren's Syndrome
- What is being tested?
- TCM (Gan-Lu-Yin)GLY
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 May 2016to 31 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥20 years old
- Written informed consent obtained
- Been diagnosed with the diagnostic criteria for Sjogren's syndrome (according to the 2002 European Classification Standard)
- The ESSPRI score of the patient of Sjogren's syndrome at least> 3
Who cannot join
- Have association disease about heart, lung, nerve or mental
- Pregnant or breastfeeding women
- Laboratory abnormality:
- Serum creatinine ≥2.0 mg/dl
- Male: Hb≤9 g/dl;Female: Hb≤8.5 g/dl
- Neutrophil or lymphocyte<0.5 x 109/l
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.
To investigate the efficacy and safety of traditional Chinese medicine in patients with Sjogren's syndrome.
Read the detailed description
This is 2 years' double blind, randomized, placebo-controlled clinical trial. Patients fulfilled the classification criteria of Sjogren syndrome will be recruited. Eligible subjects will be randomized on a 2:1 ratio to Traditional Chinese Medicine (TCM) granules or placebo for 12 weeks. The treatment group will receive a combination formula with traditional Chinese medicine, Gan-Lu-Yin in the morning and Jia-wei-Xiao-yao-San in the evening. Primary endpoint is the ESSPRI, European Sjogren Syndrome Patient Reported Outcome Index. Secondary endpoints include disease activity index (ESSDAI) , patient global assessment (PGA), VAS pain scale, Quality of Life by Short Form-36 (SF-36), fatigue scale and related serological markers. Thirty patients will be enrolled in the first year. After interim analysis at the end of first year, sample size will be recalculated base on the interim analysis results.
- Conditions
- Sjögren's Syndrome
- Being tested
- TCM (Gan-Lu-Yin)GLY, PLACEBO
- Keywords
- Sjögren's syndrome, Traditional Chinese Medicine, Herbs, Clinical trial, Gan-Lu-Yin, Jia-wei-Xiao-yao-San, Ye-Jiao-Teng, Suan-Zao-Ren
- 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.
TCM (Gan-Lu-Yin)GLYDrug
Also called Gan-Lu-Yin
TCM Gan-Lu-Yin 6g in the morning TCM Jia-Wei-Xiao-Yao-San, Ye-Jiao-Teng, Suan-Zao-Ren 8g in the evening for 12 weeks
PLACEBODrug
TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| TCM Gan-Lu-Yin (GLY) | Experimental | TCM Gan-Lu-Yin 6g in the morning TCM Jia-Wei-Xiao-Yao-San, Ye-Jiao-Teng, Suan-Zao-Ren 8g in the evening for 12 weeks Receives: Drug: TCM (Gan-Lu-Yin)GLY |
| PLACEBO | Placebo comparator | TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks Receives: Drug: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at week 12
The investigators use ESSPRI to compared the difference between the week 12 and 0
Measured: week 0, week 12
Secondary outcomes (8)
Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 4
The investigators use ESSDAI to compared the difference between the the week 4 and 0
Measured: week 0, week 4
Physicians Global Assessment to measure quality of life (PGA)
The investigators use PGA to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0
Measured: week 0, week 4, week 8, week 12
Visual Analog Scale for pain (VAS)
The investigators use VAS to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0
Measured: week 0, week 4, week 8, week 12
Quality of life by SF-36
The investigators use SF-36 to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0
Measured: week 0, week 4, week 8, week 12
modified fatigue impact scale (MFI)
The investigators use MFI to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0
Measured: week 0, week 4, week 8, week 12
Pittsburgh Sleep Quality Index (PSQI)
The investigators use PSQI to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0
Measured: week 0, week 4, week 8, week 12
Body Constitution Questionnaire (BCQ)
The investigators use BCQ to compared the difference between the week 12 and 0, the week 8 and 0, the week 4 and 0
Measured: week 0, week 4, week 8, week 12
Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 8
The investigators use ESSDAI to compared the difference between the week 8 and 0
Measured: week 0, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2019
- Study start6 May 2016
- Primary completion31 Oct 2017
- Study completion31 Dec 2017
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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheng-Chung Wei, Chung Shan Medical University
- Investigators
- Wei C- C, M, Principal investigator, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04111341
- Sponsor's protocol ID
- CS16051
- Status last verified
- Sep 2019
- First submitted
- 26 Sep 2019
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.
- ClinicalTrials.gov ID
- NCT04111341
- Acronym / sponsor ID
- CS16051
- Conditions
- Sjögren's Syndrome
- Keywords
- Sjögren's syndrome, Traditional Chinese Medicine, Herbs, Clinical trial, Gan-Lu-Yin, Jia-wei-Xiao-yao-San, Ye-Jiao-Teng, Suan-Zao-Ren
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- 6 May 2016 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 1 Oct 2019 (actual)
- 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 investigate the efficacy and safety of traditional Chinese medicine in patients with Sjogren's syndrome.
Detailed description
This is 2 years' double blind, randomized, placebo-controlled clinical trial. Patients fulfilled the classification criteria of Sjogren syndrome will be recruited. Eligible subjects will be randomized on a 2:1 ratio to Traditional Chinese Medicine (TCM) granules or placebo for 12 weeks. The treatment group will receive a combination formula with traditional Chinese medicine, Gan-Lu-Yin in the morning and Jia-wei-Xiao-yao-San in the evening. Primary endpoint is the ESSPRI, European Sjogren Syndrome Patient Reported Outcome Index. Secondary endpoints include disease activity index (ESSDAI) , patient global assessment (PGA), VAS pain scale, Quality of Life by Short Form-36 (SF-36), fatigue scale and related serological markers. Thirty patients will be enrolled in the first year. After interim analysis at the end of first year, sample size will be recalculated base on the interim analysis results.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM Gan-Lu-Yin (GLY) | Experimental | Drug: TCM (Gan-Lu-Yin)GLYTCM Gan-Lu-Yin 6g in the morning TCM Jia-Wei-Xiao-Yao-San, Ye-Jiao-Teng, Suan-Zao-Ren 8g in the evening for 12 weeks |
| PLACEBO | Placebo comparator | Drug: PLACEBOTCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥20 years old
- Written informed consent obtained
- Been diagnosed with the diagnostic criteria for Sjogren's syndrome (according to the 2002 European Classification Standard)
- The ESSPRI score of the patient of Sjogren's syndrome at least> 3
Key exclusion criteria (6 listed)
- Have association disease about heart, lung, nerve or mental
- Pregnant or breastfeeding women
- Laboratory abnormality:
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 |
|---|---|---|
| TCM (Gan-Lu-Yin)GLYAlso: Gan-Lu-YinTCM Gan-Lu-Yin 6g in the morning TCM Jia-Wei-Xiao-Yao-San, Ye-Jiao-Teng, Suan-Zao-Ren 8g in the evening for 12 weeks | Drug | TCM Gan-Lu-Yin (GLY) |
| PLACEBOTCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks | Drug | PLACEBO |
Primary outcome
Change from baseline EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at week 12
Time frame: week 0, week 12
The investigators use ESSPRI to compared the difference between the week 12 and 0
8 secondary outcomes
Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 4
Time frame: week 0, week 4
Physicians Global Assessment to measure quality of life (PGA)
Time frame: week 0, week 4, week 8, week 12
Visual Analog Scale for pain (VAS)
Time frame: week 0, week 4, week 8, week 12
Quality of life by SF-36
Time frame: week 0, week 4, week 8, week 12
modified fatigue impact scale (MFI)
Time frame: week 0, week 4, week 8, week 12
Pittsburgh Sleep Quality Index (PSQI)
Time frame: week 0, week 4, week 8, week 12
Body Constitution Questionnaire (BCQ)
Time frame: week 0, week 4, week 8, week 12
Change from baseline EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) at week 8
Time frame: week 0, week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Wei C- C, M principal investigator
Chung Shan Medical 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 TCM (Gan-Lu-Yin)GLY in people with Sjögren's Syndrome, run by Chung Shan Medical University 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 1 Oct 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at week 12 (time frame: week 0, week 12). 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 1 Oct 2019.