NCT05656196

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 19, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

August 9, 2022

Last Update Submit

January 24, 2024

Conditions

Dry Eye SyndromeSjogren's SyndromeXerophthalmia

Keywords

Dry Eye SyndromeSjogren's SyndromeXerophthalmiaChinese herbal teaNourishing Yin and Moistening Dryness

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • TCM pattern

    8 weeks

  • TCM tongue diagnosis

    8 weeks

  • TCM pulse diagnosis

    8 weeks

  • TCM heart rate variability

    8 weeks

  • Whole-genome genotyping(TWBv2.0)

    8 weeks

  • +4 more secondary outcomes

Study Arms (3)

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.

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.

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.

Other: Chinese herbal tea VGH-DESJS-1

Interventions

Chinese herbal tea VGH-DESJS-1OTHER

Chinese herbal tea VGH-DESJS-1.

Dry eye syndrome (DES)Non DES SJS Healthy Controls (NHC)Sjögren's syndrome (SJS)

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Sjögren's syndrome
  • non AIDDES Healthy Controls

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ching-Mao Chang

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Dry Eye SyndromesSjogren's SyndromeXerophthalmia

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesConjunctival Diseases

Study Officials

  • Ching-Mao Chang, M.D., Ph.D.

    Center for Traditional Medicine, Taipei Veterans General Hospital, Taipei, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 30 dry eye syndrome subjects, 60 Sjögren's syndrome' dry eye subjects, and 10 non DES SJS Healthy Controls, NHC)
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2022

First Posted

December 19, 2022

Study Start

April 1, 2023

Primary Completion

June 30, 2023

Study Completion

December 31, 2023

Last Updated

January 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)