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.

NCT06605495 | Not Yet Recruiting DMC

• 1 other identifier: 2024YH008
• Study Type: interventional
• Target: 4,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (3)

• Chinese Medical Evidence Scale

  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.

  From enrollment to end of 6-week treatment

• Ocular Surface Disease Index

  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.

  From enrollment to end of 6-week treatment

• Fluorescein Breakup Time

  Efficacy was evaluated by the values tested before and after the intervention

  From enrollment to end of 6-week treatment

Secondary Outcomes (4)

• 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

Study Arms (3)

Chinese Medicine External Treatment Group

ACTIVE COMPARATOR

Combination Product: fumigation with Chinese medicine

Chinese Medicine Internal Treatment Group (Oral Herbal Medicine)

EXPERIMENTAL

Drug: Oral herbal medicine

Western medicine treatment group

ACTIVE COMPARATOR

Drug: Modern Western Medicine

Interventions

fumigation with Chinese medicine COMBINATION_PRODUCT

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

Chinese Medicine External Treatment Group

Oral herbal medicine 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.

Chinese Medicine Internal Treatment Group (Oral Herbal Medicine)

Modern Western Medicine DRUG

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

Western medicine treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuejing Lu: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Fumigation; Phytotherapy

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health; Complementary Therapies; Therapeutics

Central Study Contacts

Lu

CONTACT

18908178510; luxuejing@cdutcm.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician of Traditional Chinese Medicine Ophthalmology, Ineye Hospital of Chengdu University of TCM

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 20, 2024
• Study Start: September 25, 2024
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share