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Набор скоро начнётся NCT07037823

Effectiveness of the Combination Strategy of Disease-Modifying Therapy and the Yishen Daluo Yin Modified Formula for Multiple Sclerosis

— Наблюдательное RRMS

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: Modified Yishen Daluo Yin formula.
Кому может быть актуально
Состояния в реестре: RRMS. Базовые параметры: от 18 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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Официальное название

Effectiveness of the Combination Strategy of Disease-Modifying Therapy and the Yishen Daluo Yin Modified Formula for Multiple Sclerosis: A Prospective Multi-Center Observational Comparative Study

Обзор

This study was designed to investigate the effectiveness of a combined strategy utilizing disease-modifying therapy and the modified Yishen Daluo Yin formula for relapsing-remitting multiple sclerosis (RRMS) through a prospective, multicenter, observational comparative study.

Вмешательства

  • Другое Modified Yishen Daluo Yin formula
    The specific application of the modified Yishen Daluo Yin formula, including the starting point, dosage, and duration of treatment, should be determined based on medical advice, the patient's condition, and their individual preferences.

Первичные конечные точки

  • The proportion of patients exhibiting no evidence of disease activity (NEDA) -3 at 48 weeks. [Срок оценки: From enrollment to week 48.]
Вторичные конечные точки (12)
  • Annual Relapse Rate [Срок оценки: From enrollment to week 24 and week 48.]
  • Proportion of Patients Without Relapse [Срок оценки: From enrollment to week 12, 24, 36, and 48.]
  • Changes in EDSS Compared to Baseline [Срок оценки: From enrollment to week 12, 24, 36, and 48.]
  • The proportion of patients with confirmed disability progression within 3 months. [Срок оценки: From enrollment to week 12, 24, 36, and 48.]
  • The proportion of patients with confirmed disability progression within 6 months. [Срок оценки: From enrollment to week 24 and week 48.]
  • Number of newly added gadolinium enhanced T1 lesions [Срок оценки: From enrollment to week 48.]
  • Total number of gadolinium-enhanced T1 lesions [Срок оценки: From enrollment to week 48.]
  • Changes in T1 lesion volume compared with baseline [Срок оценки: From enrollment to week 24 and week 48.]
  • Number of newly added or enlargement gadolinium enhanced T2 lesions. [Срок оценки: From enrollment to week 24 and week 48.]
  • Changes in T2 lesion volume compared with baseline [Срок оценки: From enrollment to week 24 and week 48.]
  • Proportion of patients with treatment interruption [Срок оценки: From enrollment to week 12, 24, 36, and 48.]
  • Proportion of patients who terminated treatment [Срок оценки: From enrollment to week 12, 24, 36, and 48.]

Критерии участия

Критерии включения

  • Participants who are over 18 years old at the time of signing the informed consent form, with no gender restrictions.
  • Participants meet the diagnostic criteria for multiple sclerosis (MS) as outlined in the 2017 McDonald's diagnostic criteria and the 2023 edition of the Chinese Guidelines for the Diagnosis and Treatment of Multiple Sclerosis.
  • No clinical relapse, as defined in the protocol, has occurred for 30 days or more prior to screening and baseline (Day 1).
  • Patients receiving first-line DMT drug treatment at a stable dosage. (The first-line DMT drugs involved in this study have stable dosages: Teriflunomide (14 mg, oral, once daily), Dimethyl Fumarate (240 mg, oral, twice daily), Fingolimod Hydrochloride (0.5 mg, oral, once daily), Siponimod (1 mg or 2 mg daily), Ozanimod (0.92 mg, oral, once daily), Ofatumumab (20 mg, subcutaneous injection once every 28 days), and Glatiramer Acetate (20 mg, subcutaneous injection once daily or 40 mg, three times a week).)
  • Signing the informed consent form.
  • Participants were able to engage in clinical follow-up throughout the entire study period.

Критерии исключения

  • According to the 2017 McDonald's guidelines and the 2023 version of the Chinese Multiple Sclerosis Diagnosis and Treatment Guidelines, individuals diagnosed with progressive MS, including both primary progressive MS (PPMS) and secondary progressive MS (SPMS), are excluded.
  • Participants who cannot performe MRI scans in certain situations include individuals with known allergic reactions to gadolinium contrast agents or those with other contraindications.
  • The expected lifespan is less than one year.
  • Participants who cannot complet the study due to mental illness, cognitive or emotional disorders.
  • Pregnant or lactating women.
  • Patients who are currently receiving or participating in other immunosuppressive, immunomodulatory, MS DMT treatment or clinical trials.
  • Any situation that other researchers deem inappropriate for participation in this study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07037823 · 2024DZMEC-605

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗