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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-06

Study Completion Date

2024-12-31

Brief Summary

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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

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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

Conditions

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Dry Eye Syndrome Xerophthalmia

Keywords

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dry eye syndromes Xerophthalmia acupuncture GB20 BL2 Oral microbiota

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

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.

Oral microbiota

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the oral microbiota analysis.

Schirmer's test

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the Schirmer's test.

Tear breakup time

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the tear breakup time test.

OSDI(Ocular Surface Disease Index)

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the OSDI test.

TCM pattern

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine pattern diagnosis.

Traditional Chinese Medicine (TCM) tongue diagnosis

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) tongue diagnosis.

TCM pulse diagnosis

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) pulse diagnosis.

TCM heart rate variability

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the TCM Heart rate variability.

ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the ESSPRI.

Whole-genome genotyping(TWBv2.0)

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the Whole-genome genotyping(TWBv2.0).

Cytokine markers

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the cytokine markers(IL-17、MMP-9、BAFF、BCMA) analysis.

Blood biochemical analysis

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the Blood biochemical analysis(BUN,Cre,AST,ALT,ESR and CRP).

complete blood count (CBC)

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the CBC(WBC、RBC、Hb、Platelet) analysis.

SF-36(36-Item Short Form Survey )

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the SF-36 test.

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.

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

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.

Oral microbiota

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the oral microbiota analysis.

Schirmer's test

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the Schirmer's test.

Tear breakup time

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the tear breakup time test.

OSDI(Ocular Surface Disease Index)

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the OSDI test.

TCM pattern

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine pattern diagnosis.

Traditional Chinese Medicine (TCM) tongue diagnosis

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) tongue diagnosis.

TCM pulse diagnosis

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) pulse diagnosis.

TCM heart rate variability

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the TCM Heart rate variability.

ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the ESSPRI.

Whole-genome genotyping(TWBv2.0)

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the Whole-genome genotyping(TWBv2.0).

Cytokine markers

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the cytokine markers(IL-17、MMP-9、BAFF、BCMA) analysis.

Blood biochemical analysis

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the Blood biochemical analysis(BUN,Cre,AST,ALT,ESR and CRP).

complete blood count (CBC)

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the CBC(WBC、RBC、Hb、Platelet) analysis.

SF-36(36-Item Short Form Survey )

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the SF-36 test.

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.

Group Type OTHER

Oral microbiota

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the oral microbiota analysis.

TCM pattern

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine pattern diagnosis.

Traditional Chinese Medicine (TCM) tongue diagnosis

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) tongue diagnosis.

TCM pulse diagnosis

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) pulse diagnosis.

TCM heart rate variability

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the TCM Heart rate variability.

Whole-genome genotyping(TWBv2.0)

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the Whole-genome genotyping(TWBv2.0).

Cytokine markers

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the cytokine markers(IL-17、MMP-9、BAFF、BCMA) analysis.

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.

Group Type OTHER

Oral microbiota

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the oral microbiota analysis.

Schirmer's test

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the Schirmer's test.

Tear breakup time

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the tear breakup time test.

OSDI(Ocular Surface Disease Index)

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the OSDI test.

TCM pattern

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine pattern diagnosis.

Traditional Chinese Medicine (TCM) tongue diagnosis

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) tongue diagnosis.

TCM pulse diagnosis

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) pulse diagnosis.

TCM heart rate variability

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the TCM Heart rate variability.

ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the ESSPRI.

Whole-genome genotyping(TWBv2.0)

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the Whole-genome genotyping(TWBv2.0).

Cytokine markers

Intervention Type DIAGNOSTIC_TEST

Group GB20, Group GB20 plus BL2 and Healthy control will take the cytokine markers(IL-17、MMP-9、BAFF、BCMA) analysis.

Blood biochemical analysis

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the Blood biochemical analysis(BUN,Cre,AST,ALT,ESR and CRP).

complete blood count (CBC)

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the CBC(WBC、RBC、Hb、Platelet) analysis.

SF-36(36-Item Short Form Survey )

Intervention Type DIAGNOSTIC_TEST

Group GB20 and Group GB20 plus BL2 will take the SF-36 test.

Interventions

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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.

Intervention Type PROCEDURE

Oral microbiota

Group GB20, Group GB20 plus BL2 and Healthy control will take the oral microbiota analysis.

Intervention Type DIAGNOSTIC_TEST

Schirmer's test

Group GB20 and Group GB20 plus BL2 will take the Schirmer's test.

Intervention Type DIAGNOSTIC_TEST

Tear breakup time

Group GB20 and Group GB20 plus BL2 will take the tear breakup time test.

Intervention Type DIAGNOSTIC_TEST

OSDI(Ocular Surface Disease Index)

Group GB20 and Group GB20 plus BL2 will take the OSDI test.

Intervention Type DIAGNOSTIC_TEST

TCM pattern

Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine pattern diagnosis.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

TCM pulse diagnosis

Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) pulse diagnosis.

Intervention Type DIAGNOSTIC_TEST

TCM heart rate variability

Group GB20, Group GB20 plus BL2 and Healthy control will take the TCM Heart rate variability.

Intervention Type DIAGNOSTIC_TEST

ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)

Group GB20 and Group GB20 plus BL2 will take the ESSPRI.

Intervention Type DIAGNOSTIC_TEST

Whole-genome genotyping(TWBv2.0)

Group GB20, Group GB20 plus BL2 and Healthy control will take the Whole-genome genotyping(TWBv2.0).

Intervention Type 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.

Intervention Type 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).

Intervention Type DIAGNOSTIC_TEST

complete blood count (CBC)

Group GB20 and Group GB20 plus BL2 will take the CBC(WBC、RBC、Hb、Platelet) analysis.

Intervention Type DIAGNOSTIC_TEST

SF-36(36-Item Short Form Survey )

Group GB20 and Group GB20 plus BL2 will take the SF-36 test.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

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

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chang Ching-Mao, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

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Ching-Mao Chang

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chang Ching-Mao, M.D., Ph.D.

Role: CONTACT

Phone: 886-28757453

Email: [email protected]

Facility Contacts

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Chang Ching-Mao, M.D., Ph.D.

Role: primary

Other Identifiers

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2020-07-003C

Identifier Type: -

Identifier Source: org_study_id