Health TrialsbyHealthPanel

Exosome-miRNA and Transcriptome Profiling of Dry Eye Syndrome and Sjogren's Syndrome

ConditionsDry Eye SyndromeSjogren's SyndromeXerophthalmia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-75
SponsorTaipei Veterans General Hospital, Taiwan

About this trial

This study combines data from two trials testing acupuncture (ACUDES) and a Chinese herbal tea bag TBDESJS for Dry Eye Syndrome and Sjögren's syndrome. Both treatments improved tear production. Researchers will now analyze participants' blood remaining samples and other data to understand how these therapies work. They will use advanced methods to identify tiny RNA molecules and immune system activity. This integrated approach aims to explain how acupuncture and TBDESJS improve dryness and support their use in managing these conditions.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

aged between 20 and 75 years Schirmer's test less than 10 mm/5 min

Disqualifiers

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.

Inclusion Criteria: aged between 20 and 75 years without any Chronic disease

Exclusion Criteria: any Sjögren's syndrome or Dry eye syndrome.

Trial population

1. Dry Eye Syndrome (DES): Participants diagnosed with Dry Eye Syndrome, characterized by symptoms such as ocular discomfort, dryness, and visual disturbances. 2. Sjögren's Syndrome (SS):Patients diagnosed with Sjögren's Syndrome, an autoimmune disorder marked by dry eyes and mouth, often accompanied by systemic manifestations. 3. non AIDDES Healthy Controls (NHC): Healthy individuals without any history of dry eye symptoms or autoimmune diseases, serving as a control group.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • TBDESJS

    Other intervention

    Chinese herbal tea TBDESJS

  • Acupuncture

    Other intervention

    acupuncture GB20 or GB20 plus BL2

Treatment groups

220 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Group GB201 intervention
Group B: Group GB20 plus BL21 intervention
Group C: non AIDDES Healthy Controls (NHC)1 intervention
Group D: Waiting list1 intervention
Group E: Dry eye syndrome (DES)1 intervention
Group F: Sjögren's syndrome (SJS)1 intervention

Trial outcomes

Primary outcomes

1

Schirmer's test

Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the Schirmer's test.

Time frame
8 weeks
2

Ocular Surface Disease Index (OSDI)

Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the OSDI(Ocular Surface Disease Index).

Time frame
8 weeks

Secondary outcomes

1

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.

Time frame
8 weeks
2

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.

Time frame
8 weeks
3

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.

Time frame
8 weeks
4

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.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taipei Veterans General Hospital, Taiwan

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: