Demyelinating Diseases of the Central Nervous System Registry for Patients With Traditional Chinese Medicine (DATE-TCM)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Traditional Chinese medicine (TCM).
- Кому может быть актуально
- Состояния в реестре: Demyelinating Diseases of the Central Nervous System (DDC). Базовые параметры: 18 лет — 65 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Demyelinating Diseases of the Central Nervous System Registry for Patients with Traditional Chinese Medicine (DATE-TCM) is an observational study aiming to better define the multidimensional (epidemiologic, demographic and clinical) characteristics of Demyelinating Diseases of the Central Nervous System (DDC) patients receiving Traditional Chinese medicine (TCM) treatment, the type and long-term safety and effectiveness of TCM in DDC populations, as well as the interaction of TCM treatment and disease-modifying therapy in the management of DDC.
Подробное описание
Demyelinating Diseases of the Central Nervous System (DDC) is a collective term for a group of immune-mediated disorders including multiple sclerosis, Neuromyelitis optica spectrum disorder, and myelin oligodendrocyte glycoprotein associated disorder, characterized by myelin loss and axonal damage in the central nervous system. Traditional Chinese medicine (TCM), a main form of complementary and alternative medicine provides a potential possibility to DDC management and has been applied to a considerable number of patients with this disorder in China as well as in other regions or countries worldwide. Demyelinating Diseases of the Central Nervous System Registry for Patients with Traditional Chinese Medicine (DATE-TCM) provides a prospective and voluntary registry aiming to include 2000 eligible adult DDC patients with TCM intervenes from around 30 participating centers by using a web-based system. Baseline data will be recorded and subsequently regular follow-up visits will be implemented every 3-6 months for a total of 5 years. Main objective of DATE-TCM is to create an organized multicenter structure to collect reliable data for better define the multidimensional (epidemiologic, demographic and clinical) characteristics of DDC patients receiving TCM treatment, the type and long-term safety and effectiveness of TCM in DDC populations, as well as the interaction of TCM treatment and disease-modifying therapy in the management of DDC.
Вмешательства
- Другое Traditional Chinese medicine (TCM)
TCM treatment includes Chinese herbal medicine, acupuncture, moxibustion, massage, taiji, and qigong.
Первичные конечные точки
- Annualized Aggregate Relapse Rate (ARR) [Срок оценки: Baseline up to 5 years]
Вторичные конечные точки (12)
- Total Number of Adverse Events During Evaluation [Срок оценки: Baseline up to 5 years]
- Percentage of Participants With Adverse Events [Срок оценки: Baseline up to 5 years]
- Time to 3-month Sustained Disability Progression [Срок оценки: 5 years]
- Time to 6-month Sustained Disability Progression [Срок оценки: 5 years]
- Number of New or Newly Enlarging T2 hyperintense lesions as Measured by Magnetic Resonance Imaging (MRI) [Срок оценки: From baseline to 12 months, 24 months, 36 months, 48 months, 60 months]
- Number of Gadolinium-enhancing T1-weighted Lesions as Measured by Magnetic Resonance Imaging (MRI) [Срок оценки: From baseline to 12 months, 24 months, 36 months, 48 months, 60 months]
- Percent Change in Brain Volume Measured by Magnetic Resonance Imaging (MRI) [Срок оценки: From baseline to 12 months, 24 months, 36 months, 48 months, 60 months]
- Change in Multiple Sclerosis Functional Composite (MSFC) score [Срок оценки: Every 6 months up to 5 years]
- Change in Symbol Digit Modalities Test (SDMT) score [Срок оценки: Every 6 months up to 5 years]
- Chance in fatigue severity scale (FSS) score [Срок оценки: Every 6 months up to 5 years]
- Change in EuroQol- 5 Dimension (EQ-5D) score [Срок оценки: Every 6 months up to 5 years]
- Change from Multiple Sclerosis impact scale (MSIS) score [Срок оценки: Every 6 months up to 5 years]
Критерии участия
Критерии включения
- Male or female participants with aged 18-65 years old; Diagnosis of DDC including multiple sclerosis (MS), Neuromyelitis optica spectrum disorder (NMOSD), and myelin oligodendrocyte glycoprotein-associated disease(MOGAD) according to relevant criteria or consensus; Patients who receive or are willing to receive TCM treatment including the Chinese herbal medicine, acupuncture, moxibustion, massage, taiji, and qigong; Informed written consent obtained from the patient, and/or his/her legally authorized representatives.
Критерии исключения
- Refusal to give informed consent; Malignancies, infectious diseases (HBV, HCV, HIV, etc.), congenital or acquired severe immunodeficiency, significant cardiovascular, pulmonary, and hepatic diseases or conditions; Mental disturbance or severe cognitive impairment impeding necessary information gathering and assessment.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT05415579 · DDCR-TCM-2022