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. (DED OSDI FBUT)

Xuejing Lu

Status: Not yet enrolling

Conditions: Dry Eye Disease (DED)

Treatments: Combination Product: fumigation with Chinese medicine; Drug: Modern Western Medicine; Drug: Oral herbal medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT06605495

2024YH008

Details and patient eligibility

About

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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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4,000 participants in 3 patient groups

Chinese Medicine External Treatment Group

Active Comparator group

Treatment:

Combination Product: fumigation with Chinese medicine

Chinese Medicine Internal Treatment Group (Oral Herbal Medicine)

Experimental group

Treatment:

Drug: Oral herbal medicine

Western medicine treatment group

Active Comparator group

Treatment:

Drug: Modern Western Medicine