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.

Официальное название

Demonstration Clinical Study of Dry Eye Disease Advantage

Обзор

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.

Вмешательства

• Комбинированный продукт fumigation with Chinese medicine
  Eye fumigation with the Eyesight Eye Therapy,10 minutes once daily for 6 weeks.
• Препарат 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.
• Препарат Modern Western Medicine
  Referring to the Chinese Expert Consensus on Dry Eye: Treatment (2020), this course of treatment totaled 6 weeks.

Первичные конечные точки

• Chinese Medical Evidence Scale [Срок оценки: From enrollment to end of 6-week treatment]
• Ocular Surface Disease Index [Срок оценки: From enrollment to end of 6-week treatment]
• Fluorescein Breakup Time [Срок оценки: From enrollment to end of 6-week treatment]

Вторичные конечные точки (4)

• Schirmer Ⅰ test [Срок оценки: From enrollment to end of 6-week treatment]
• Height of the River of Tears [Срок оценки: From enrollment to end of 6-week treatment]
• fluorescent staining of the cornea [Срок оценки: From enrollment to end of 6-week treatment]
• Classification of blepharoplasty deficiency [Срок оценки: From enrollment to end of 6-week treatment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06605495 · 2024YH008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗