Dry Eye SyndromeNCT05656196
VGH-DESJS-1 in Ocular and Oral Dryness Symptoms of Dry Eye Syndrome and Sjögren's Syndrome
A study testing Chinese herbal tea VGH-DESJS-1 in people with Dry Eye Syndrome and Sjogren's Syndrome, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
To evaluate the Chinese herbal tea VGH-DESJS-1 in ocular and oral dryness symptoms of Dry eye syndrome and Sjögren's syndrome Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome, Sjogren's Syndrome, Xerophthalmia
- What is being tested?
- Chinese herbal tea VGH-DESJS-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2023to 31 Dec 2023
- Phase
- Interventional
- 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
Dry eye syndrome
-Inclusion Criteria: aged between 20 and 75 years Schirmer's test less than 10 mm/5 min
-Exclusion Criteria: Pregnancy With eye inflammation or infectious eye disease Accepted operation of eye
Sjögren's syndrome
-Inclusion Criteria: primary or secondary SS aged between 20 and 75 years fulfilled the 2002 American-European Consensus Criteria for SS (AECG) had no abnormal findings of immune, liver, kidney, or blood function evaluations.
-Exclusion Criteria: a history of alcohol abuse, diabetes mellitus, or major life-threatening condition pregnancy or breastfeeding steroid pulse therapy within three months prior to the commencement of our study.
non AIDDES Healthy Controls
-Inclusion Criteria: aged between 20 and 75 years without any Chronic disease
-Exclusion Criteria: any Sjögren's syndrome or Dry eye syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Evaluate the Chinese Herbal Tea VGH-DESJS-1 in Ocular and Oral Dryness Symptoms of Dry Eye Syndrome and Sjögren's Syndrome
To evaluate the Chinese herbal tea VGH-DESJS-1 in ocular and oral dryness symptoms of Dry eye syndrome and Sjögren's syndrome
Read the detailed description
Method: This study wants to evaluate the Chinese herbal tea VGH-DESJS-1 on Nourishing Yin and Moistening Dryness the ocular dryness from dry eye syndrome (DES) and Sjögren's syndrome (SJS). One hundred dry eye subjects are composed of 30 dry eye syndrome subjects, 60 Sjögren's syndrome' dry eye subjects, and 10 non DES SJS Healthy Controls, NHC). DES, SJS, and NHC received VGH-DESJS-1 daily during 8 weeks for the evaluation before and after the subjects receiving the VGH-DESJS-1. Moreover, we could use the Whole-genome genotyping, Schirmer's test, Tear breakup time (TBUT), Cytokines, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), Traditional Chinese Medicine (TCM) pattern, TCM tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability, and it could be applied for the goal of holistic health care.
Expected Results:
- To evaluate the difference among Schirmer's test, TBUT, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, heart rate variability, Whole-genome genotyping, and Cytokines for DES, SJS, and NHC.
- To evaluate the Nourishing Yin and Moistening Dryness of VGH-DESJS-1 for DES and SJS.
- To evaluate the Nourishing Yin and Moistening Dryness of VGH-DESJS-1 for DES.
- To evaluate the Nourishing Yin and Moistening Dryness of VGH-DESJS-1 for SJS.
Keywords: Dry eye syndrome, Sjögren's syndrome, Xerophthalmia, Chinese herbal tea, Nourishing Yin and Moistening Dryness
- Conditions
- Dry Eye Syndrome, Sjogren's Syndrome, Xerophthalmia
- Being tested
- Chinese herbal tea VGH-DESJS-1
- Keywords
- Dry Eye Syndrome, Sjogren's Syndrome, Xerophthalmia, Chinese herbal tea, Nourishing Yin and Moistening Dryness
- Medical subject headings
- Dry Eye Syndromes, Sjogren's Syndrome, Xerophthalmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbal tea VGH-DESJS-1Other
Chinese herbal tea VGH-DESJS-1.
| Study group | Role | What they receive |
|---|---|---|
| Dry eye syndrome (DES) | Experimental | Dry eye syndrome (DES) will received Chinese herbal tea VGHTPE-DESJS-1 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation. And we could use the Schirmer's test, Tear breakup time, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), cytokine markers, Whole-genome genotyping, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. Receives: Other: Chinese herbal tea VGH-DESJS-1 |
| Sjögren's syndrome (SJS) | Experimental | Sjögren's syndrome (SJS) will received Chinese herbal tea VGHTPE-DESJS-1 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation. And we could use the Schirmer's test, Tear breakup time, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), cytokine markers, Whole-genome genotyping, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. Receives: Other: Chinese herbal tea VGH-DESJS-1 |
| Non DES SJS Healthy Controls (NHC) | Experimental | Non DES SJS Healthy Controls (NHC) will received Chinese herbal tea VGHTPE-DESJS-1 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation. And we could use the Schirmer's test, Tear breakup time, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), cytokine markers, Whole-genome genotyping, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. Receives: Other: Chinese herbal tea VGH-DESJS-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Schirmer's test
Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the Schirmer's test.
Measured: 8 weeks
Ocular Surface Disease Index (OSDI)
Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the OSDI(Ocular Surface Disease Index).
Measured: 8 weeks
Secondary outcomes (9)
TCM pattern
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls (NHC) take the TCM pattern to differentiate the 9 types of TCM constitutions.
Measured: 8 weeks
TCM tongue diagnosis
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls (NHC) take the TCM tongue diagnosis with camera photo to differentiate the TCM tongue feature factors about Tongue body, Tongue Coating, Red spot, Tooth marks, and Ecchymosis. TCM tongue feature factors would present the status of inflammation, blood stasis, heat, dampness with TCM theory.
Measured: 8 weeks
TCM pulse diagnosis
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls (NHC) take the TCM pulse diagnosis with blood pressure monitors to differentiate the TCM pulse feature factors about Floating, Deep, Slow, Rapid, Deficient, Excessive, Slippery, Rough, String-like, Soggy, Fine, Weak. TCM tongue feature factors would present the status of inflammation, blood stasis, heat, dampness with TCM theory.
Measured: 8 weeks
TCM heart rate variability
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls (NHC) take the TCM heart rate variability.
Measured: 8 weeks
Whole-genome genotyping(TWBv2.0)
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls (NHC) take the Whole-genome genotyping (TWBv2.0).
Measured: 8 weeks
Cytokine markers
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls, NHC) take the cytokine markers (IL-17, MMP-9, BAFF, BCMA) analysis.
Measured: 8 weeks
Pittsburgh Sleep Quality Index
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls, NHC) take the Pittsburgh Sleep Quality Index
Measured: 8 weeks
Ford Insomnia Response to Stress Test
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls, NHC) take the Ford Insomnia Response to Stress Test.
Measured: 8 weeks
EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls, NHC) take the EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Apr 2023
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 30 dry eye syndrome subjects, 60 Sjögren's syndrome' dry eye subjects, and 10 non DES SJS Healthy Controls, NHC)
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ching-Mao Chang, M.D., Ph.D., Principal investigator, Center for Traditional Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656196
- Sponsor's protocol ID
- 2022-08-011A
- Status last verified
- Jan 2024
- First submitted
- 9 Aug 2022
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Chinese Herbal Tea VGH-DESJS-1 in Ocular and Oral Dryness Symptoms of Dry Eye Syndrome and Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT05656196
- Acronym / sponsor ID
- 2022-08-011A
- Conditions
- Dry Eye Syndrome, Sjogren's Syndrome, Xerophthalmia
- Keywords
- Dry Eye Syndrome, Sjogren's Syndrome, Xerophthalmia, Chinese herbal tea, Nourishing Yin and Moistening Dryness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Dec 2022 (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 evaluate the Chinese herbal tea VGH-DESJS-1 in ocular and oral dryness symptoms of Dry eye syndrome and Sjögren's syndrome
Detailed description
Method: This study wants to evaluate the Chinese herbal tea VGH-DESJS-1 on Nourishing Yin and Moistening Dryness the ocular dryness from dry eye syndrome (DES) and Sjögren's syndrome (SJS). One hundred dry eye subjects are composed of 30 dry eye syndrome subjects, 60 Sjögren's syndrome' dry eye subjects, and 10 non DES SJS Healthy Controls, NHC). DES, SJS, and NHC received VGH-DESJS-1 daily during 8 weeks for the evaluation before and after the subjects receiving the VGH-DESJS-1. Moreover, we could use the Whole-genome genotyping, Schirmer's test, Tear breakup time (TBUT), Cytokines, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), Traditional Chinese Medicine (TCM) pattern, TCM tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability, and it could be applied for the goal of holistic health care.
Expected Results:
- To evaluate the difference among Schirmer's test, TBUT, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, heart rate variability, Whole-genome genotyping, and Cytokines for DES, SJS, and NHC.
- To evaluate the Nourishing Yin and Moistening Dryness of VGH-DESJS-1 for DES and SJS.
- To evaluate the Nourishing Yin and Moistening Dryness of VGH-DESJS-1 for DES.
- To evaluate the Nourishing Yin and Moistening Dryness of VGH-DESJS-1 for SJS.
Keywords: Dry eye syndrome, Sjögren's syndrome, Xerophthalmia, Chinese herbal tea, Nourishing Yin and Moistening Dryness
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 30 dry eye syndrome subjects, 60 Sjögren's syndrome' dry eye subjects, and 10 non DES SJS Healthy Controls, NHC)
| Arm | Type | Receives |
|---|---|---|
| Dry eye syndrome (DES) | Experimental | Other: Chinese herbal tea VGH-DESJS-1Dry eye syndrome (DES) will received Chinese herbal tea VGHTPE-DESJS-1 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation. And we could use the Schirmer's test, Tear breakup time, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), cytokine markers, Whole-genome genotyping, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. |
| Sjögren's syndrome (SJS) | Experimental | Other: Chinese herbal tea VGH-DESJS-1Sjögren's syndrome (SJS) will received Chinese herbal tea VGHTPE-DESJS-1 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation. And we could use the Schirmer's test, Tear breakup time, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), cytokine markers, Whole-genome genotyping, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. |
| Non DES SJS Healthy Controls (NHC) | Experimental | Other: Chinese herbal tea VGH-DESJS-1Non DES SJS Healthy Controls (NHC) will received Chinese herbal tea VGHTPE-DESJS-1 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation. And we could use the Schirmer's test, Tear breakup time, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), cytokine markers, Whole-genome genotyping, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Chinese herbal tea VGH-DESJS-1Chinese herbal tea VGH-DESJS-1. | Other | Dry eye syndrome (DES), Non DES SJS Healthy Controls (NHC), Sjögren's syndrome (SJS) |
Primary outcome
Schirmer's test
Time frame: 8 weeks
Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the Schirmer's test.
Ocular Surface Disease Index (OSDI)
Time frame: 8 weeks
Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the OSDI(Ocular Surface Disease Index).
9 secondary outcomes
TCM pattern
Time frame: 8 weeks
TCM tongue diagnosis
Time frame: 8 weeks
TCM pulse diagnosis
Time frame: 8 weeks
TCM heart rate variability
Time frame: 8 weeks
Whole-genome genotyping(TWBv2.0)
Time frame: 8 weeks
Cytokine markers
Time frame: 8 weeks
Pittsburgh Sleep Quality Index
Time frame: 8 weeks
Ford Insomnia Response to Stress Test
Time frame: 8 weeks
EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Time frame: 8 weeks
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 26 Jan 2024.
- 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.
Ching-Mao Chang, M.D., Ph.D. principal investigator
Center for Traditional Medicine, Taipei Veterans General Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese herbal tea VGH-DESJS-1 in people with Dry Eye Syndrome and Sjogren's Syndrome, run by Taipei Veterans General Hospital, Taiwan 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?
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 26 Jan 2024. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Schirmer's test (time frame: 8 weeks). The study lists 2 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 26 Jan 2024.