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

Dry Eye Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04877483
• Other study ID #: 2020-07-003C
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Chang Ching-Mao, M.D., Ph.D.
• Phone: 886-28757453
• Email: magicbjp[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome
• Xerophthalmia

Intervention

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

Locations

Country	Name	City	State
Taiwan	Ching-Mao Chang	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Schirmer's test	Schirmer's test is a tool for evaluating aqueous tear production among the dry eye syndrome.	one year
Primary	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.	one year
Secondary	TCM pattern	TCM pattern is a tool for detecting the constitution among the Dry eye syndrome (DES) and healthy control.	one year
Secondary	TCM tongue diagnosis	TCM tongue diagnosis is a tool for detecting tongue expression among the Dry eye syndrome (DES) and healthy control.	one year
Secondary	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.	one year
Secondary	TCM pulse diagnosis	TCM tongue diagnosis is a tool for detecting tongue expression pulse pattern among the Dry eye syndrome (DES) and healthy control.	one year
Secondary	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).	one year
Secondary	ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)	ESSPRI is a tool for evaluating the symptoms of SJS among the dry eye syndrome.	one year
Secondary	Tear breakup time (TBUT)	Tear breakup time (TBUT) is a clinical test used to assess for evaporative dry eye disease.	one year
Secondary	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-1ß,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-ß1,IFN-a,IFN-aR,IFN-?,IFN-?R,TNFRSF4,BLK,CXCR5,CXCL10 to find the difference with the comparison between the dry eye syndrome and healthy control.	one year
Secondary	Oral microbiota	By using the Oral microbiota analysis to find the difference with the comparison between the dry eye syndrome and healthy control.	one year
Secondary	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.	one year
Secondary	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.	one year
Secondary	CBC(complete blood count)	A complete blood count (CBC) is a blood test used to evaluate overall health among the Dry eye syndromes.	one year