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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

4000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-25

Study Completion Date

2025-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Dry Eye Disease (DED)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Chinese Medicine External Treatment Group

Group Type ACTIVE_COMPARATOR

fumigation with Chinese medicine

Intervention Type COMBINATION_PRODUCT

Eye fumigation with the Eyesight Eye Therapy,10 minutes once daily for 6 weeks.

Chinese Medicine Internal Treatment Group (Oral Herbal Medicine)

Group Type EXPERIMENTAL

Oral herbal medicine

Intervention Type DRUG

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.

Western medicine treatment group

Group Type ACTIVE_COMPARATOR

Modern Western Medicine

Intervention Type DRUG

Referring to the Chinese Expert Consensus on Dry Eye: Treatment (2020), this course of treatment totaled 6 weeks.

Interventions

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fumigation with Chinese medicine

Eye fumigation with the Eyesight Eye Therapy,10 minutes once daily for 6 weeks.

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type DRUG

Modern Western Medicine

Referring to the Chinese Expert Consensus on Dry Eye: Treatment (2020), this course of treatment totaled 6 weeks.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No