VGH-DESJS-1 in Ocular and Oral Dryness Symptoms of Dry Eye Syndrome and Sjögren's Syndrome

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05656196

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

8.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome Sjogren's Syndrome Xerophthalmia	Other: Chinese herbal tea VGH-DESJS-1	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

30 dry eye syndrome subjects, 60 Sjögren's syndrome' dry eye subjects, and 10 non DES SJS Healthy Controls, NHC)30 dry eye syndrome subjects, 60 Sjögren's syndrome' dry eye subjects, and 10 non DES SJS Healthy Controls, NHC)

Masking:

None (Open Label)

Primary Purpose:

Other

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dry eye syndrome (DES) 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.	Other: Chinese herbal tea VGH-DESJS-1 Chinese herbal tea VGH-DESJS-1 is composed of Lilium lancifolium, Ophiopogon japonicus, Schizandra chinensis, Chrysanthemum morifolium, Polygala tenuifolia, Ziziphus jujuba, and Paeonia lactiflora, which its' ratio is 2 g:2 g:1.5 g:1.5 g:1.5 g:1.5 g:1 g.
Experimental: Sjögren's syndrome (SJS) 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.	Other: Chinese herbal tea VGH-DESJS-1 Chinese herbal tea VGH-DESJS-1 is composed of Lilium lancifolium, Ophiopogon japonicus, Schizandra chinensis, Chrysanthemum morifolium, Polygala tenuifolia, Ziziphus jujuba, and Paeonia lactiflora, which its' ratio is 2 g:2 g:1.5 g:1.5 g:1.5 g:1.5 g:1 g.
Experimental: Non DES SJS Healthy Controls (NHC) 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.	Other: Chinese herbal tea VGH-DESJS-1 Chinese herbal tea VGH-DESJS-1 is composed of Lilium lancifolium, Ophiopogon japonicus, Schizandra chinensis, Chrysanthemum morifolium, Polygala tenuifolia, Ziziphus jujuba, and Paeonia lactiflora, which its' ratio is 2 g:2 g:1.5 g:1.5 g:1.5 g:1.5 g:1 g.

Arm

Intervention/Treatment

Experimental: Dry eye syndrome (DES)

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.

Other: Chinese herbal tea VGH-DESJS-1

Chinese herbal tea VGH-DESJS-1 is composed of Lilium lancifolium, Ophiopogon japonicus, Schizandra chinensis, Chrysanthemum morifolium, Polygala tenuifolia, Ziziphus jujuba, and Paeonia lactiflora, which its' ratio is 2 g:2 g:1.5 g:1.5 g:1.5 g:1.5 g:1 g.

Experimental: Sjögren's syndrome (SJS)

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.

Other: Chinese herbal tea VGH-DESJS-1

Experimental: Non DES SJS Healthy Controls (NHC)

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.

Other: Chinese herbal tea VGH-DESJS-1

Outcome Measures

Primary Outcome Measures

Schirmer's test [8 weeks]
Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the Schirmer's test.
Tear breakup time (TBUT) [8 weeks]
Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the Tear breakup time.
Ocular Surface Disease Index (OSDI) [8 weeks]
Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the OSDI(Ocular Surface Disease Index).

Secondary Outcome Measures

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.
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.
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).
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.
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.