Demonstration Clinical Study of Dry Eye Disease Advantage
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4,000
- 主要终点
- Chinese Medical Evidence Scale
研究概览
简要总结
In this study, dry eye disease (leukoaraiosis) is used as a model disease, and the methodological system for evaluating the clinical efficacy of Chinese medicine for dry eye disease is constructed with the core of "subgrouping dynamic and static parallel group design", so as to carry out a real-world demonstration study of dry eye disease as a dominant disease in Chinese medicine treatment. The purpose of this study is to demonstrate the selection of individualized clinical interventions and the superiority of dynamic diagnosis and treatment using dry eye as a disease model. The study provides a clinical example of a subgroup-based dynamic and static parallel group design for TCM clinical research on "disease-based integrated treatment". Based on the conclusions of the efficacy evaluation study, we will provide real-world clinical data of dry eye syndrome for the artificial intelligence prediction of the integrated platform of individualized clinical evaluation and evidence support of Chinese medicine with multi-source data integration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be 18-75 years of age and of any gender; Meets Western diagnostic criteria for dry eye; formed consent and signed the Informed Consent Form
排除标准
- •Those who are unable to perform a dry eye examination due to various factors; Patients with severe diseases of the liver or renal system, or infectious eye diseases; Those who are allergic to the medications used in this study; Women who are pregnant or breastfeeding; Mental illness or intellectual disability; Participants in clinical trials of other drugs within the last 3 months.
研究组 & 干预措施
Chinese Medicine External Treatment Group
干预措施: fumigation with Chinese medicine (Combination Product)
Chinese Medicine Internal Treatment Group (Oral Herbal Medicine)
干预措施: Oral herbal medicine (Drug)
Western medicine treatment group
干预措施: Modern Western Medicine (Drug)
结局指标
主要结局
Chinese Medical Evidence Scale
时间窗: From enrollment to end of 6-week treatment
The TCM evidence scale converts symptoms and signs into TCM evidence, and assigns 1, 2, and 3 points according to three levels of severity, with reference to the "Guiding Principles for Clinical Research on New Drugs of Traditional Chinese Medicine" and the "International TCM Clinical Practice Guidelines for Stemmed Eyes (2021-12-14)". If the points of TCM evidence are higher or unchanged after the intervention, it means that the intervention measures are ineffective or inefficient, and that patients\' clinical symptoms do not improve significantly or their conditions worsen after the treatment. If the TCM syndrome score increases or remains unchanged after the intervention compared with that before treatment, it means that the intervention is ineffective or inefficient, and the patient\'s clinical symptoms do not improve or worsen after treatment.
Ocular Surface Disease Index
时间窗: From enrollment to end of 6-week treatment
By evaluating the points before and after the intervention treatment, if the points are lower than before the treatment, it suggests that the intervention treatment is effective, on the contrary, it indicates that the intervention is ineffective or ineffective, and the clinical symptoms of the patients do not improve significantly or worsen after the treatment.
Fluorescein Breakup Time
时间窗: From enrollment to end of 6-week treatment
Efficacy was evaluated by the values tested before and after the intervention
次要结局
- Schirmer Ⅰ test(From enrollment to end of 6-week treatment)
- Height of the River of Tears(From enrollment to end of 6-week treatment)
- fluorescent staining of the cornea(From enrollment to end of 6-week treatment)
- Classification of blepharoplasty deficiency(From enrollment to end of 6-week treatment)
研究者
Xuejing Lu
Chief Physician of Traditional Chinese Medicine Ophthalmology, Ineye Hospital of Chengdu University of TCM
Ineye Hospital of Chengdu University of Traditional Chinese Medicine