Using Dry Eye As a Disease Model, Investigators Demonstrated the Optimal Selection of Individualized Clinical Interventions and the Superiority of Dynamic Treatment Discrimination in Chinese Medicine.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: fumigation with Chinese medicine, Oral herbal medicine, Modern Western Medicine.
- Who it may be relevant to
- Registry conditions: Dry Eye Disease (DED). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Demonstration Clinical Study of Dry Eye Disease Advantage
Overview
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, investigators 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.
Interventions
- Combination product fumigation with Chinese medicine
Eye fumigation with the Eyesight Eye Therapy,10 minutes once daily for 6 weeks. - Drug Oral herbal medicine
Patients were identified into the appropriate group according to the individual evidence profile, and the herbal formula under the corresponding evidence profile was taken orally as one dose of 150 ml of water twice a day for 6 weeks. - Drug Modern Western Medicine
Referring to the Chinese Expert Consensus on Dry Eye: Treatment (2020), this course of treatment totaled 6 weeks.
Primary outcome measures
- Chinese Medical Evidence Scale [Time frame: From enrollment to end of 6-week treatment]
- Ocular Surface Disease Index [Time frame: From enrollment to end of 6-week treatment]
- Fluorescein Breakup Time [Time frame: From enrollment to end of 6-week treatment]
Secondary outcome measures (4)
- Schirmer Ⅰ test [Time frame: From enrollment to end of 6-week treatment]
- Height of the River of Tears [Time frame: From enrollment to end of 6-week treatment]
- fluorescent staining of the cornea [Time frame: From enrollment to end of 6-week treatment]
- Classification of blepharoplasty deficiency [Time frame: From enrollment to end of 6-week treatment]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06605495 · 2024YH008