Dry Eye Syndrome, Sjogren's Syndrome, Xerophthalmia
Conditions
Keywords
Dry Eye Syndrome, Sjogren's Syndrome, Xerophthalmia, Chinese herbal tea, Nourishing Yin and Moistening Dryness
Brief summary
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: 1. 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. 2. To evaluate the Nourishing Yin and Moistening Dryness of VGH-DESJS-1 for DES and SJS. 3. To evaluate the Nourishing Yin and Moistening Dryness of VGH-DESJS-1 for DES. 4. 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
Interventions
OTHERChinese herbal tea VGH-DESJS-1
Chinese herbal tea VGH-DESJS-1.
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
30 dry eye syndrome subjects, 60 Sjögren's syndrome' dry eye subjects, and 10 non DES SJS Healthy Controls, NHC)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Schirmer's test | 8 weeks | Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the Schirmer's test. |
| Ocular Surface Disease Index (OSDI) | 8 weeks | Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the OSDI(Ocular Surface Disease Index). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TCM pulse diagnosis | 8 weeks | 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. |
| TCM heart rate variability | 8 weeks | Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls (NHC) take the TCM heart rate variability. |
| Whole-genome genotyping(TWBv2.0) | 8 weeks | Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls (NHC) take the Whole-genome genotyping (TWBv2.0). |
| TCM pattern | 8 weeks | 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. |
| Pittsburgh Sleep Quality Index | 8 weeks | Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls, NHC) take the Pittsburgh Sleep Quality Index |
| Ford Insomnia Response to Stress Test | 8 weeks | Dry eye syndrome (DES), Sjögren's syndrome (SJS), and on DES SJS Healthy Controls, NHC) take the Ford Insomnia Response to Stress Test. |
| EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) | 8 weeks | 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) |
| Cytokine markers | 8 weeks | 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. |
| TCM tongue diagnosis | 8 weeks | 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. |
Countries
Taiwan
Outcome results
None listed