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

December 11, 2022 updated by: Taipei Veterans General Hospital, Taiwan
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  1. 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.
  2. Integrated functional multi-omics for dry eye syndrome and healthy control.
  3. To evaluate the efficacy of GB20 plus BL2 for dry eye syndrome and Sjögren's syndrome.
  4. To evaluate the efficacy of GB20 for dry eye syndrome and Sjögren's syndrome.
  5. 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

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Locations

  • Taiwan
      • Taipei, Taiwan, 112
        • Recruiting
        • Ching-Mao Chang
        • Contact:
          • Chang Ching-Mao, M.D., Ph.D.
          • Phone Number: 88628757453 Ext. 333
          • Email: magicbjp@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group GB20
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.
Procedure: Acupuncture
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.
Diagnostic test: Oral microbiota
Group GB20, Group GB20 plus BL2 and Healthy control will take the oral microbiota analysis.
Diagnostic test: Schirmer's test
Group GB20 and Group GB20 plus BL2 will take the Schirmer's test.
Diagnostic test: Tear breakup time
Group GB20 and Group GB20 plus BL2 will take the tear breakup time test.
Diagnostic test: OSDI(Ocular Surface Disease Index)
Group GB20 and Group GB20 plus BL2 will take the OSDI test.
Diagnostic test: TCM pattern
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine pattern diagnosis.
Diagnostic test: Traditional Chinese Medicine (TCM) tongue diagnosis
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) tongue diagnosis.
Diagnostic test: TCM pulse diagnosis
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) pulse diagnosis.
Diagnostic test: TCM heart rate variability
Group GB20, Group GB20 plus BL2 and Healthy control will take the TCM Heart rate variability.
Diagnostic test: ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)
Group GB20 and Group GB20 plus BL2 will take the ESSPRI.
Diagnostic test: Whole-genome genotyping(TWBv2.0)
Group GB20, Group GB20 plus BL2 and Healthy control will take the Whole-genome genotyping(TWBv2.0).
Diagnostic test: Cytokine markers
Group GB20, Group GB20 plus BL2 and Healthy control will take the cytokine markers(IL-17、MMP-9、BAFF、BCMA) analysis.
Diagnostic test: Blood biochemical analysis
Group GB20 and Group GB20 plus BL2 will take the Blood biochemical analysis(BUN,Cre,AST,ALT,ESR and CRP).
Diagnostic test: complete blood count (CBC)
Group GB20 and Group GB20 plus BL2 will take the CBC(WBC、RBC、Hb、Platelet) analysis.
Diagnostic test: SF-36(36-Item Short Form Survey )
Group GB20 and Group GB20 plus BL2 will take the SF-36 test.
Experimental: Group GB20 plus BL2
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.
Procedure: Acupuncture
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.
Diagnostic test: Oral microbiota
Group GB20, Group GB20 plus BL2 and Healthy control will take the oral microbiota analysis.
Diagnostic test: Schirmer's test
Group GB20 and Group GB20 plus BL2 will take the Schirmer's test.
Diagnostic test: Tear breakup time
Group GB20 and Group GB20 plus BL2 will take the tear breakup time test.
Diagnostic test: OSDI(Ocular Surface Disease Index)
Group GB20 and Group GB20 plus BL2 will take the OSDI test.
Diagnostic test: TCM pattern
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine pattern diagnosis.
Diagnostic test: Traditional Chinese Medicine (TCM) tongue diagnosis
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) tongue diagnosis.
Diagnostic test: TCM pulse diagnosis
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) pulse diagnosis.
Diagnostic test: TCM heart rate variability
Group GB20, Group GB20 plus BL2 and Healthy control will take the TCM Heart rate variability.
Diagnostic test: ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)
Group GB20 and Group GB20 plus BL2 will take the ESSPRI.
Diagnostic test: Whole-genome genotyping(TWBv2.0)
Group GB20, Group GB20 plus BL2 and Healthy control will take the Whole-genome genotyping(TWBv2.0).
Diagnostic test: Cytokine markers
Group GB20, Group GB20 plus BL2 and Healthy control will take the cytokine markers(IL-17、MMP-9、BAFF、BCMA) analysis.
Diagnostic test: Blood biochemical analysis
Group GB20 and Group GB20 plus BL2 will take the Blood biochemical analysis(BUN,Cre,AST,ALT,ESR and CRP).
Diagnostic test: complete blood count (CBC)
Group GB20 and Group GB20 plus BL2 will take the CBC(WBC、RBC、Hb、Platelet) analysis.
Diagnostic test: SF-36(36-Item Short Form Survey )
Group GB20 and Group GB20 plus BL2 will take the SF-36 test.
Other: Healthy control
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.
Diagnostic test: Oral microbiota
Group GB20, Group GB20 plus BL2 and Healthy control will take the oral microbiota analysis.
Diagnostic test: TCM pattern
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine pattern diagnosis.
Diagnostic test: Traditional Chinese Medicine (TCM) tongue diagnosis
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) tongue diagnosis.
Diagnostic test: TCM pulse diagnosis
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) pulse diagnosis.
Diagnostic test: TCM heart rate variability
Group GB20, Group GB20 plus BL2 and Healthy control will take the TCM Heart rate variability.
Diagnostic test: Whole-genome genotyping(TWBv2.0)
Group GB20, Group GB20 plus BL2 and Healthy control will take the Whole-genome genotyping(TWBv2.0).
Diagnostic test: Cytokine markers
Group GB20, Group GB20 plus BL2 and Healthy control will take the cytokine markers(IL-17、MMP-9、BAFF、BCMA) analysis.
Other: Waiting list
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.
Diagnostic test: Oral microbiota
Group GB20, Group GB20 plus BL2 and Healthy control will take the oral microbiota analysis.
Diagnostic test: Schirmer's test
Group GB20 and Group GB20 plus BL2 will take the Schirmer's test.
Diagnostic test: Tear breakup time
Group GB20 and Group GB20 plus BL2 will take the tear breakup time test.
Diagnostic test: OSDI(Ocular Surface Disease Index)
Group GB20 and Group GB20 plus BL2 will take the OSDI test.
Diagnostic test: TCM pattern
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine pattern diagnosis.
Diagnostic test: Traditional Chinese Medicine (TCM) tongue diagnosis
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) tongue diagnosis.
Diagnostic test: TCM pulse diagnosis
Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) pulse diagnosis.
Diagnostic test: TCM heart rate variability
Group GB20, Group GB20 plus BL2 and Healthy control will take the TCM Heart rate variability.
Diagnostic test: ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)
Group GB20 and Group GB20 plus BL2 will take the ESSPRI.
Diagnostic test: Whole-genome genotyping(TWBv2.0)
Group GB20, Group GB20 plus BL2 and Healthy control will take the Whole-genome genotyping(TWBv2.0).
Diagnostic test: Cytokine markers
Group GB20, Group GB20 plus BL2 and Healthy control will take the cytokine markers(IL-17、MMP-9、BAFF、BCMA) analysis.
Diagnostic test: Blood biochemical analysis
Group GB20 and Group GB20 plus BL2 will take the Blood biochemical analysis(BUN,Cre,AST,ALT,ESR and CRP).
Diagnostic test: complete blood count (CBC)
Group GB20 and Group GB20 plus BL2 will take the CBC(WBC、RBC、Hb、Platelet) analysis.
Diagnostic test: SF-36(36-Item Short Form Survey )
Group GB20 and Group GB20 plus BL2 will take the SF-36 test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Schirmer's test
Time Frame: one year
Schirmer's test is a tool for evaluating aqueous tear production among the dry eye syndrome.
one year
OSDI(Ocular Surface Disease Index)
Time Frame: one year
OSDI(Ocular Surface Disease Index) is a tool to rate the severity of dry eye disease among the dry eye syndrome.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TCM pattern
Time Frame: one year
TCM pattern is a tool for detecting the constitution among the Dry eye syndrome (DES) and healthy control.
one year
TCM tongue diagnosis
Time Frame: one year
TCM tongue diagnosis is a tool for detecting tongue expression among the Dry eye syndrome (DES) and healthy control.
one year
Heart rate variability (HRV)
Time Frame: one year
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.
one year
TCM pulse diagnosis
Time Frame: one year
TCM tongue diagnosis is a tool for detecting tongue expression pulse pattern among the Dry eye syndrome (DES) and healthy control.
one year
SF-36(36-Item Short Form Survey )
Time Frame: one year
SF-36 is a tool for evaluating Health-Related Quality of Life among the Dry eye syndrome (DES).
one year
ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)
Time Frame: one year
ESSPRI is a tool for evaluating the symptoms of SJS among the dry eye syndrome.
one year
Tear breakup time (TBUT)
Time Frame: one year
Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease.
one year
Whole-genome genotyping(TWBv2.0)
Time Frame: one year
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.
one year
Oral microbiota
Time Frame: one year
By using the Oral microbiota analysis to find the difference with the comparison between the dry eye syndrome and healthy control.
one year
Blood biochemical analysis
Time Frame: one year
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.
one year
Cytokine biomarkers
Time Frame: one year
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.
one year
CBC(complete blood count)
Time Frame: one year
A complete blood count (CBC) is a blood test used to evaluate overall health among the Dry eye syndromes.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Chang Ching-Mao, M.D., Ph.D., Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

May 4, 2021

First Submitted That Met QC Criteria

May 4, 2021

First Posted (Actual)

May 7, 2021

Study Record Updates

Last Update Posted (Estimate)

December 13, 2022

Last Update Submitted That Met QC Criteria

December 11, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-07-003C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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