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

Not Applicable

Completed

• Conditions: Dry Eye Syndrome; Xerophthalmia; Sjogren's Syndrome
• Interventions: Other: Chinese herbal tea VGH-DESJS-1

• Registration Number: NCT05656196
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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

Study Timeline

• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-12-11
• Study First Posted: 2022-12-19
• Study Start: 2023-04-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non DES SJS Healthy Controls (NHC)	Chinese herbal tea VGH-DESJS-1	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.
Dry eye syndrome (DES)	Chinese herbal tea VGH-DESJS-1	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.
Sjögren's syndrome (SJS)	Chinese herbal tea VGH-DESJS-1	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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
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)
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.
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.
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.
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.

Trial Locations

Locations (1)

Ching-Mao Chang; 🇨🇳 Taipei, Taiwan