To Evaluate the Chinese Herbal Tea VGH-DESJS-1 in Ocular and Oral Dryness Symptoms of Dry Eye Syndrome and Sjögren's Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Schirmer's test
研究概览
简要总结
To evaluate the Chinese herbal tea VGH-DESJS-1 in ocular and oral dryness symptoms of Dry eye syndrome and Sjögren's syndrome
详细描述
Method: This study wants to evaluate the Chinese herbal tea VGH-DESJS-1 on Nourishing Yin and Moistening Dryness the ocular dryness from dry eye syndrome (DES) and Sjögren's syndrome (SJS). One hundred dry eye subjects are composed of 30 dry eye syndrome subjects, 60 Sjögren's syndrome' dry eye subjects, and 10 non DES SJS Healthy Controls, NHC). DES, SJS, and NHC received VGH-DESJS-1 daily during 8 weeks for the evaluation before and after the subjects receiving the VGH-DESJS-1. Moreover, we could use the Whole-genome genotyping, Schirmer's test, Tear breakup time (TBUT), Cytokines, Ocular Surface Disease Index (OSDI), EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI), Pittsburgh Sleep Quality Index (PSQI), Ford Insomnia Response to Stress Test (FIRST), Traditional Chinese Medicine (TCM) pattern, TCM tongue diagnosis, TCM pulse diagnosis, and TCM heart rate variability, and it could be applied for the goal of holistic health care.
Expected Results:
- To evaluate the difference among Schirmer's test, TBUT, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, heart rate variability, Whole-genome genotyping, and Cytokines for DES, SJS, and NHC.
- To evaluate the Nourishing Yin and Moistening Dryness of VGH-DESJS-1 for DES and SJS.
- To evaluate the Nourishing Yin and Moistening Dryness of VGH-DESJS-1 for DES.
- To evaluate the Nourishing Yin and Moistening Dryness of VGH-DESJS-1 for SJS.
Keywords: Dry eye syndrome, Sjögren's syndrome, Xerophthalmia, Chinese herbal tea, Nourishing Yin and Moistening Dryness
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged between 20 and 75 years Schirmer's test less than 10 mm/5 min
排除标准
- •Pregnancy With eye inflammation or infectious eye disease Accepted operation of eye
- •Sjögren's syndrome
- •Inclusion Criteria: primary or secondary SS aged between 20 and 75 years fulfilled the 2002 American-European Consensus Criteria for SS (AECG) had no abnormal findings of immune, liver, kidney, or blood function evaluations.
- •Exclusion Criteria: a history of alcohol abuse, diabetes mellitus, or major life-threatening condition pregnancy or breastfeeding steroid pulse therapy within three months prior to the commencement of our study.
- •non AIDDES Healthy Controls
- •Inclusion Criteria: aged between 20 and 75 years without any Chronic disease
- •Exclusion Criteria: any Sjögren's syndrome or Dry eye syndrome.
结局指标
主要结局
Schirmer's test
时间窗: 8 weeks
Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the Schirmer's test.
Ocular Surface Disease Index (OSDI)
时间窗: 8 weeks
Dry eye syndrome (DES) and Sjögren's syndrome (SJS) take the OSDI(Ocular Surface Disease Index).
次要结局
- TCM pulse diagnosis(8 weeks)
- TCM heart rate variability(8 weeks)
- Whole-genome genotyping(TWBv2.0)(8 weeks)
- Pittsburgh Sleep Quality Index(8 weeks)
- EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)(8 weeks)
- TCM pattern(8 weeks)
- Cytokine markers(8 weeks)
- Ford Insomnia Response to Stress Test(8 weeks)
- TCM tongue diagnosis(8 weeks)