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

To evaluate the Chinese herbal tea VGH-DESJS-1 in ocular and oral dryness symptoms of Dry eye syndrome and Sjögren's syndrome

Study Overview

• Status: Completed
• Conditions: Sjogren's Syndrome; Dry Eye Syndrome; Xerophthalmia
• Intervention / Treatment: Other: Chinese herbal tea VGH-DESJS-1

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ching-Mao Chang, M.D., Ph.D.; Phone Number: 333 886-28757453; Email: magicbjp@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 112
    • Ching-Mao Chang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Schirmer's test	Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the Schirmer's test.	8 weeks
Ocular Surface Disease Index (OSDI)	Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the OSDI(Ocular Surface Disease Index).	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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).	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.	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	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.	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)	8 weeks

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Ching-Mao Chang, M.D., Ph.D., Center for Traditional Medicine, Taipei Veterans General Hospital, Taipei, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: August 9, 2022
• First Submitted That Met QC Criteria: December 11, 2022
• First Posted (Actual): December 19, 2022

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Sjogren's Syndrome; Dry Eye Syndrome; Xerophthalmia; Chinese herbal tea; Nourishing Yin and Moistening Dryness
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Sjogren's Syndrome; Xerophthalmia
• Other Study ID Numbers: 2022-08-011A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No