Health TrialsbyHealthPanel

Exosomes Proteomic for Sjogren's Syndrome and Dry Eye Syndrome

ConditionsDry Eye Syndrome (DES)Sjogren's SyndromeXerophthalmia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-75
SponsorTaipei Veterans General Hospital, Taiwan

About this trial

By analyzing the differential proteins in exosomes, this study aims to understand the pathological mechanisms of SJS and DES, identify potential diagnostic and therapeutic methods, and advance the diagnosis and treatment of these diseases.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Dry Eye Syndrome (DES): Participants diagnosed with Dry Eye Syndrome, characterized by symptoms such as ocular discomfort, dryness, and visual disturbances. Sjögren's Syndrome (SS):Patients diagnosed with Sjögren's Syndrome, an autoimmune disorder marked by dry eyes and mouth, often accompanied by systemic manifestations. 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

  • acupuncture GB20 or GB20 plus BL2

    Other intervention

    acupuncture at acupoint GB20 or GB20 plus BL2 twice a week 8 weeks for efficacy evaluation.

  • Chinese herbal tea TBDESJS

    Drug

    Chinese herbal tea TBDESJS 8 weeks on Nourishing Yin and Moistening Dryness the ocular dryness evaluation.

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)2 interventions
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
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