NCT04877483

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

Status unknown NA Last updated 13 December 2022

What this trial tests

NA trial testing Acupuncture in Dry Eye Syndrome in 120 participants. Status unknown.

Timeline

6 December 2022

Primary endpoint
31 December 2022

31 December 2024

Quick facts

Lead sponsor	Taipei Veterans General Hospital, Taiwan
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	120
Start date	6 December 2022
Primary completion	31 December 2022
Estimated completion	31 December 2024
Sites	1 location across Taiwan

Drugs / interventions tested

• Acupuncture — full drug profile →
• 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 )

Conditions studied

• Dry Eye Syndrome — all drugs for Dry Eye Syndrome →
• Xerophthalmia — all drugs for Xerophthalmia →

Sponsor

Taipei Veterans General Hospital, Taiwan

Who can join

Adults 20 to 75, any sex, with Dry Eye Syndrome or Xerophthalmia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Dry eye syndrome: comprehensive etiologies and recent clinical trials.
   Huang R, Su C, Fang L, Lu J, et al · · 2022 · cited 52× · PMID 35678897 · DOI 10.1007/s10792-022-02320-7