NCT04877483

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

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: 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

• Dry Eye Syndrome
• Xerophthalmia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-06
• Primary completion: 2022-12-31
• Completion: 2024-12-31
• First posted: 2021-05-07
• Last updated: 2022-12-13

Locations

1 site across 1 country: Taiwan