Clinical trial NCT04877483: To Evaluate the Short-term and Long Term Efficacy of Acupuncture in Ocular and Oral Dryness Symptoms of Dry Eye Syndrome
Official title: To Evaluate the Short-term and Long Term Efficacy of Acupuncture in Ocular and Oral Dryness Symptoms of Dry Eye Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dry Eye Syndrome
Xerophthalmia
Keywords: dry eye syndromes
Xerophthalmia
acupuncture
GB20
BL2
Oral microbiota
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2021-05-07
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: * 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.

Primary outcomes:
measure: Schirmer's test
timeFrame: one year
measure: OSDI(Ocular Surface Disease Index)
timeFrame: one year
Secondary outcomes:
measure: TCM pattern
timeFrame: one year
measure: TCM tongue diagnosis
timeFrame: one year
measure: Heart rate variability (HRV)
timeFrame: one year
measure: TCM pulse diagnosis
timeFrame: one year
measure: SF-36(36-Item Short Form Survey )
timeFrame: one year
measure: ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)
timeFrame: one year
measure: Tear breakup time (TBUT)
timeFrame: one year
measure: Whole-genome genotyping(TWBv2.0)
timeFrame: one year
measure: Oral microbiota
timeFrame: one year
measure: Blood biochemical analysis
timeFrame: one year
measure: Cytokine biomarkers
timeFrame: one year
measure: CBC(complete blood count)
timeFrame: one year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Ching-Mao Chang
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Chang Ching-Mao, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: