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To Evaluate the Short-term and Long Term Efficacy of Acupuncture in Ocular and Oral Dryness Symptoms of Dry Eye Syndrome

Primary Purpose

Dry Eye Syndrome, Xerophthalmia

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acupuncture
Oral microbiota
Schirmer's test
Tear breakup time
OSDI(Ocular Surface Disease Index)
TCM pattern
Traditional Chinese Medicine (TCM) tongue diagnosis
TCM pulse diagnosis
TCM heart rate variability
ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)
Whole-genome genotyping(TWBv2.0)
Cytokine markers
Blood biochemical analysis
complete blood count (CBC)
SF-36(36-Item Short Form Survey )
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring dry eye syndromes, Xerophthalmia, acupuncture, GB20, BL2, Oral microbiota

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers
  • Dry eye syndrome

    • Inclusion Criteria:

      1. aged between 20 and 75 years
      2. Schirmer's test less than 10 mm/5 min
    • Exclusion Criteria:

      1. Pregnancy
      2. With eye inflammation or infectious eye disease
      3. Accepted operation of eye
  • Sjögren's syndrome

    • Inclusion Criteria:

      1. primary or secondary SS
      2. aged between 20 and 75 years
      3. fulfilled the 2002 American-European Consensus Criteria for SS (AECG)
      4. had no abnormal findings of immune, liver, kidney, or blood function evaluations.
    • Exclusion Criteria:

      1. a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
      2. pregnancy or breastfeeding
      3. steroid pulse therapy within three months prior to the commencement of our study.

Sites / Locations

  • Ching-Mao ChangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Other

Other

Arm Label

Group GB20

Group GB20 plus BL2

Healthy control

Waiting list

Arm Description

Group GB20 will received acupuncture at acupoint GB20 twice a week 8 weeks for efficacy evaluation. And we could use the oral microbiota, Schirmer's test, Tear breakup time, 6-GSI, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose.

Group GB20 plus BL2 will received acupuncture at acupoint GB20 plus BL2 twice a week 8 weeks for efficacy evaluation. And we could use the oral microbiota, Schirmer's test, Tear breakup time, 6-GSI, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose.

Healthy control group will not received any treatment. And we could use the oral microbiota, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability to find the difference with the comparison between the dry eye syndrome and healthy control.

Group Waiting list will not received any treatment. at acupoint GB20 plus BL2 twice a week 8 weeks for efficacy evaluation. And we could use the oral microbiota, Schirmer's test, Tear breakup time, 6-GSI, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose.

Outcomes

Primary Outcome Measures

Schirmer's test
Schirmer's test is a tool for evaluating aqueous tear production among the dry eye syndrome.
OSDI(Ocular Surface Disease Index)
OSDI(Ocular Surface Disease Index) is a tool to rate the severity of dry eye disease among the dry eye syndrome.

Secondary Outcome Measures

TCM pattern
TCM pattern is a tool for detecting the constitution among the Dry eye syndrome (DES) and healthy control.
TCM tongue diagnosis
TCM tongue diagnosis is a tool for detecting tongue expression among the Dry eye syndrome (DES) and healthy control.
Heart rate variability (HRV)
Heart rate variability (HRV) is a tool for detecting ratio betwee n High-frequency (HF) activity and low-frequency (LF) activity among the Dry eye syndrome (DES) and healthy control.
TCM pulse diagnosis
TCM tongue diagnosis is a tool for detecting tongue expression pulse pattern among the Dry eye syndrome (DES) and healthy control.
SF-36(36-Item Short Form Survey )
SF-36 is a tool for evaluating Health-Related Quality of Life among the Dry eye syndrome (DES).
ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)
ESSPRI is a tool for evaluating the symptoms of SJS among the dry eye syndrome.
Tear breakup time (TBUT)
Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease.
Whole-genome genotyping(TWBv2.0)
By using the Whole-genome genotyping(TWBv2.0) of the immune-relate gene(RF5,TNIP1 (TNFAIP3),FCGR2B,TNF,LTA,NFKBIA,STAT4,IL-1β,IL-1R,IL-6,IL-6R,IL-8,IL-8R,IL-10,IL-10R,IL-12,IL-12R,IL-17,IL-17R,IL-18,IL-18R,IL-23,IL-23R,IL-27,IL-27R,TGF-β1,IFN-α,IFN-αR,IFN-γ,IFN-γR,TNFRSF4,BLK,CXCR5,CXCL10 to find the difference with the comparison between the dry eye syndrome and healthy control.
Oral microbiota
By using the Oral microbiota analysis to find the difference with the comparison between the dry eye syndrome and healthy control.
Blood biochemical analysis
By using the blood biochemical analysis of BUN,Cre,AST,ALT,CRP and ESR to evaluate the liver function and renal function among the Dry eye syndrome.
Cytokine biomarkers
By using cytokine biomarkers analysis of IL-17,MMP-9,BAFF and BCMA to find the difference with the comparison between the dry eye syndrome and healthy control.
CBC(complete blood count)
A complete blood count (CBC) is a blood test used to evaluate overall health among the Dry eye syndromes.

Full Information

First Posted
May 4, 2021
Last Updated
December 11, 2022
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT04877483
Brief Title
To Evaluate the Short-term and Long Term Efficacy of Acupuncture in Ocular and Oral Dryness Symptoms of Dry Eye Syndrome
Official Title
To Evaluate the Short-term and Long Term Efficacy of Acupuncture in Ocular and Oral Dryness Symptoms of Dry Eye Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study wants to use a randomized, single-blind, controlled trial to evaluate the efficacy of receiving acupuncture GB20 or GB20 plus BL2 on alleviating the ocular dryness symptom from dry eye syndrome and Sjögren's syndrome. One hundred dry eye syndrome subjects are composed of 50 dry eye syndrome subjects and 50 Sjögren's syndrome' dry eye subjects, and all are randomized into 40 Group GB20 and 40 Group GB20 plus BL2 (GBL), and 20 Group Waiting list; while we also include 20 healthy controls. Fifty dry eye syndrome subjects are randomized into 20 Group GB20, 20 Group GBL and 10 Group Waiting list in first year; while both Group GB20 or GBL received acupuncture twice a week 8 weeks for efficacy evaluation, and 10 Group Waiting list receive no any acupuncture treatment. And we could use the Whole-genome genotyping, oral microbiota, Schirmer's test, Tear breakup time, Cytokines, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. In second year, another 50 dry eye syndrome subjects are also enrolled and randomized into randomized into 20 Group GB20, 20 Group GBL and 10 Group Waiting list; while both Group GB20 or GBL received acupuncture twice a week 8 weeks for efficacy evaluation with above outcome measurements, and 10 Group Waiting list receive no any acupuncture treatment. Meanwhile, we also include 20 healthy controls, and we want to find the difference with the comparison between the dry eye syndrome, Sjögren's syndrome and healthy control in second year. Through the analysis for dry eye syndrome and Sjögren's syndrome, we could find the biomarker to differentiate dry eye syndrome, Sjögren's syndrome and healthy control. In the future, this work could be applied for screening and diagnosis of pre-dry eye syndrome and Sjögren's syndrome, and this integrated TCM with Western Medicine plan could be applied for the goal of holistic health care.
Detailed Description
Method: This study wants to use a randomized, single-blind, controlled trial to evaluate the efficacy of receiving acupuncture GB20 or GB20 plus BL2 on alleviating the ocular dryness symptom from dry eye syndrome and Sjögren's syndrome. One hundred dry eye syndrome subjects are composed of 50 dry eye syndrome subjects and 50 Sjögren's syndrome' dry eye subjects, and all are randomized into 40 Group GB20 and 40 Group GB20 plus BL2 (GBL), and 20 Group Waiting list; while we also include 20 healthy controls. Fifty dry eye syndrome subjects are randomized into 20 Group GB20, 20 Group GBL and 10 Group Waiting list in first year; while both Group GB20 or GBL received acupuncture twice a week 8 weeks for efficacy evaluation, and 10 Group Waiting list receive no any acupuncture treatment. And we could use the Whole-genome genotyping, oral microbiota, Schirmer's test, Tear breakup time, Cytokines, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose. In second year, another 50 dry eye syndrome subjects are also enrolled and randomized into randomized into 20 Group GB20, 20 Group GBL and 10 Group Waiting list; while both Group GB20 or GBL received acupuncture twice a week 8 weeks for efficacy evaluation with above outcome measurements, and 10 Group Waiting list receive no any acupuncture treatment. Meanwhile, we also include 20 healthy controls, and we want to find the difference with the comparison between the dry eye syndrome, Sjögren's syndrome and healthy control in second year. Through the analysis for dry eye syndrome and Sjögren's syndrome, we could find the biomarker to differentiate dry eye syndrome, Sjögren's syndrome and healthy control. In the future, this work could be applied for screening and diagnosis of pre-dry eye syndrome and Sjögren's syndrome, and this integrated TCM with Western Medicine plan could be applied for the goal of holistic health care. Expected Results: To evaluate the difference among Schirmer's test, TBUT, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, heart rate variability, Whole-genome genotyping, oral microbiota, and Cytokines for dry eye syndrome, Sjögren's syndrome and healthy control. Integrated functional multi-omics for dry eye syndrome and healthy control. To evaluate the efficacy of GB20 plus BL2 for dry eye syndrome and Sjögren's syndrome. To evaluate the efficacy of GB20 for dry eye syndrome and Sjögren's syndrome. To evaluate the efficacy of BL2 for dry eye syndrome and Sjögren's syndrome. Keywords: Dry eye syndrome, Sjögren's syndrome, Xerophthalmia, Acupuncture, GB20, BL2

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome, Xerophthalmia
Keywords
dry eye syndromes, Xerophthalmia, acupuncture, GB20, BL2, Oral microbiota

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group GB20
Arm Type
Experimental
Arm Description
Group GB20 will received acupuncture at acupoint GB20 twice a week 8 weeks for efficacy evaluation. And we could use the oral microbiota, Schirmer's test, Tear breakup time, 6-GSI, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose.
Arm Title
Group GB20 plus BL2
Arm Type
Experimental
Arm Description
Group GB20 plus BL2 will received acupuncture at acupoint GB20 plus BL2 twice a week 8 weeks for efficacy evaluation. And we could use the oral microbiota, Schirmer's test, Tear breakup time, 6-GSI, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose.
Arm Title
Healthy control
Arm Type
Other
Arm Description
Healthy control group will not received any treatment. And we could use the oral microbiota, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability to find the difference with the comparison between the dry eye syndrome and healthy control.
Arm Title
Waiting list
Arm Type
Other
Arm Description
Group Waiting list will not received any treatment. at acupoint GB20 plus BL2 twice a week 8 weeks for efficacy evaluation. And we could use the oral microbiota, Schirmer's test, Tear breakup time, 6-GSI, OSDI, TCM pattern, Traditional Chinese Medicine (TCM) tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability for this purpose.
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture is a form of treatment that inserting very thin needles through a person's skin at specific points on the body. Group GB20 and Group GB20 plus BL2 will received the acupuncture treatment.
Intervention Type
Diagnostic Test
Intervention Name(s)
Oral microbiota
Intervention Description
Group GB20, Group GB20 plus BL2 and Healthy control will take the oral microbiota analysis.
Intervention Type
Diagnostic Test
Intervention Name(s)
Schirmer's test
Intervention Description
Group GB20 and Group GB20 plus BL2 will take the Schirmer's test.
Intervention Type
Diagnostic Test
Intervention Name(s)
Tear breakup time
Intervention Description
Group GB20 and Group GB20 plus BL2 will take the tear breakup time test.
Intervention Type
Diagnostic Test
Intervention Name(s)
OSDI(Ocular Surface Disease Index)
Intervention Description
Group GB20 and Group GB20 plus BL2 will take the OSDI test.
Intervention Type
Diagnostic Test
Intervention Name(s)
TCM pattern
Intervention Description
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine pattern diagnosis.
Intervention Type
Diagnostic Test
Intervention Name(s)
Traditional Chinese Medicine (TCM) tongue diagnosis
Intervention Description
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) tongue diagnosis.
Intervention Type
Diagnostic Test
Intervention Name(s)
TCM pulse diagnosis
Intervention Description
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) pulse diagnosis.
Intervention Type
Diagnostic Test
Intervention Name(s)
TCM heart rate variability
Intervention Description
Group GB20, Group GB20 plus BL2 and Healthy control will take the TCM Heart rate variability.
Intervention Type
Diagnostic Test
Intervention Name(s)
ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)
Intervention Description
Group GB20 and Group GB20 plus BL2 will take the ESSPRI.
Intervention Type
Diagnostic Test
Intervention Name(s)
Whole-genome genotyping(TWBv2.0)
Intervention Description
Group GB20, Group GB20 plus BL2 and Healthy control will take the Whole-genome genotyping(TWBv2.0).
Intervention Type
Diagnostic Test
Intervention Name(s)
Cytokine markers
Intervention Description
Group GB20, Group GB20 plus BL2 and Healthy control will take the cytokine markers(IL-17、MMP-9、BAFF、BCMA) analysis.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood biochemical analysis
Intervention Description
Group GB20 and Group GB20 plus BL2 will take the Blood biochemical analysis(BUN,Cre,AST,ALT,ESR and CRP).
Intervention Type
Diagnostic Test
Intervention Name(s)
complete blood count (CBC)
Intervention Description
Group GB20 and Group GB20 plus BL2 will take the CBC(WBC、RBC、Hb、Platelet) analysis.
Intervention Type
Diagnostic Test
Intervention Name(s)
SF-36(36-Item Short Form Survey )
Intervention Description
Group GB20 and Group GB20 plus BL2 will take the SF-36 test.
Primary Outcome Measure Information:
Title
Schirmer's test
Description
Schirmer's test is a tool for evaluating aqueous tear production among the dry eye syndrome.
Time Frame
one year
Title
OSDI(Ocular Surface Disease Index)
Description
OSDI(Ocular Surface Disease Index) is a tool to rate the severity of dry eye disease among the dry eye syndrome.
Time Frame
one year
Secondary Outcome Measure Information:
Title
TCM pattern
Description
TCM pattern is a tool for detecting the constitution among the Dry eye syndrome (DES) and healthy control.
Time Frame
one year
Title
TCM tongue diagnosis
Description
TCM tongue diagnosis is a tool for detecting tongue expression among the Dry eye syndrome (DES) and healthy control.
Time Frame
one year
Title
Heart rate variability (HRV)
Description
Heart rate variability (HRV) is a tool for detecting ratio betwee n High-frequency (HF) activity and low-frequency (LF) activity among the Dry eye syndrome (DES) and healthy control.
Time Frame
one year
Title
TCM pulse diagnosis
Description
TCM tongue diagnosis is a tool for detecting tongue expression pulse pattern among the Dry eye syndrome (DES) and healthy control.
Time Frame
one year
Title
SF-36(36-Item Short Form Survey )
Description
SF-36 is a tool for evaluating Health-Related Quality of Life among the Dry eye syndrome (DES).
Time Frame
one year
Title
ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)
Description
ESSPRI is a tool for evaluating the symptoms of SJS among the dry eye syndrome.
Time Frame
one year
Title
Tear breakup time (TBUT)
Description
Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease.
Time Frame
one year
Title
Whole-genome genotyping(TWBv2.0)
Description
By using the Whole-genome genotyping(TWBv2.0) of the immune-relate gene(RF5,TNIP1 (TNFAIP3),FCGR2B,TNF,LTA,NFKBIA,STAT4,IL-1β,IL-1R,IL-6,IL-6R,IL-8,IL-8R,IL-10,IL-10R,IL-12,IL-12R,IL-17,IL-17R,IL-18,IL-18R,IL-23,IL-23R,IL-27,IL-27R,TGF-β1,IFN-α,IFN-αR,IFN-γ,IFN-γR,TNFRSF4,BLK,CXCR5,CXCL10 to find the difference with the comparison between the dry eye syndrome and healthy control.
Time Frame
one year
Title
Oral microbiota
Description
By using the Oral microbiota analysis to find the difference with the comparison between the dry eye syndrome and healthy control.
Time Frame
one year
Title
Blood biochemical analysis
Description
By using the blood biochemical analysis of BUN,Cre,AST,ALT,CRP and ESR to evaluate the liver function and renal function among the Dry eye syndrome.
Time Frame
one year
Title
Cytokine biomarkers
Description
By using cytokine biomarkers analysis of IL-17,MMP-9,BAFF and BCMA to find the difference with the comparison between the dry eye syndrome and healthy control.
Time Frame
one year
Title
CBC(complete blood count)
Description
A complete blood count (CBC) is a blood test used to evaluate overall health among the Dry eye syndromes.
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chang Ching-Mao, M.D., Ph.D.
Phone
886-28757453
Ext
333
Email
magicbjp@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Ching-Mao, M.D., Ph.D.
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ching-Mao Chang
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Ching-Mao, M.D., Ph.D.
Phone
88628757453 Ext. 333
Email
magicbjp@gmail.com

12. IPD Sharing Statement

Learn more about this trial

To Evaluate the Short-term and Long Term Efficacy of Acupuncture in Ocular and Oral Dryness Symptoms of Dry Eye Syndrome

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