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Идёт набор NCT06874803

Acupuncture and Moxibustion for Motor Symptoms in Early Parkinson's Disease

Без фазы С лечением Parkinson's Disease (PD)

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: Acupuncture and Moxibustion (AM), Sham Acupuncture and Moxibustion (Sham-AM).
Кому может быть актуально
Состояния в реестре: Parkinson's Disease (PD). Базовые параметры: 30 лет — 80 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
Китай
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

Effect of "Qi-Tonifying, Yang-Warming, and Water-Resolving" Acupuncture and Moxibustion for Motor Symptom Improvement in Early Parkinson's Disease (WARMED): A Randomized Controlled Trial

Обзор

This study evaluates the clinical effect and safety of acupuncture combined with moxibustion in improving motor symptoms of early-stage Parkinson's Disease (PD) patients, by assessing the changes in UPDRS scores. It also explores objective factors affecting the acupuncture effect and investigates the functional MRI mechanisms of acupuncture in PD treatment.

Вмешательства

  • Процедура Acupuncture and Moxibustion (AM)
    Acupuncture and moxibustion group (AM): Acupuncture at Shuifen (CV9), bilateral Yinlingquan (SP9), bilateral Zhongliao (BL33), and bilateral Weiyang (BL39), combined with moxibustion at Shuifen (CV9) and Zhongliao (BL33).
  • Процедура Sham Acupuncture and Moxibustion (Sham-AM)
    Sham acupuncture and moxibustion group (sham-AM): Acupuncture at non-acuipoints of bilateral Hegu (LI4) and bilateral Zusanli (ST36), with fake moxibustion at Shuifen (CV9) and bilateral Zhongliao (BL33).

Первичные конечные точки

  • The score change from baseline in the MDS-UPDRS part III after 8-week treatment [Срок оценки: evaluation time points: baseline, week 8.]
Вторичные конечные точки (12)
  • The score change from baseline in the MDS-UPDRS part III after 8-week follow-up [Срок оценки: evaluation time points: baseline, week 16.]
  • Changes in VAS scores of rigidity and bradykinesia after 8-week treatment and 8-week follow-up [Срок оценки: evaluation time points: baseline, week 8, week 16.]
  • The score change from baseline in the MDS-UPDRS part II after 8-week treatment and 8-week follow-up [Срок оценки: evaluation time points: baseline, week 8, week 16.]
  • The change from baseline in the MDS-UPDRS total score after 8-week treatment and 8-week follow-up [Срок оценки: evaluation time points: baseline, week 8, week 16.]
  • The proportion of participants with ≥30% decrease of MDS-UPDRS Part III after 8-week treatment and 8-week follow-up [Срок оценки: evaluation time points: baseline, week 8, week 16.]
  • The change from baseline in PDQ-39 after 8-week treatment and 8-week follow-up [Срок оценки: evaluation time points: baseline, week 8, week 16.]
  • The change from baseline in PDSS after 8-week treatment and 8-week follow-up [Срок оценки: evaluation time points: baseline, week 8, week 16.]
  • The change from baseline in SDS after 8-week treatment and 8-week follow-up [Срок оценки: evaluation time points: baseline, week 8, week 16.]
  • The change from baseline in SAS after 8-week treatment and 8-week follow-up [Срок оценки: evaluation time points: baseline, week 8, week 16.]
  • The change from baseline in functional MRI signals after 8-week treatment. [Срок оценки: evaluation time points: baseline, week 8.]
  • Subgroup analysis of gender in the score change from baseline in the MDS-UPDRS part III after 8-week treatment [Срок оценки: evaluation time points: baseline, week 8.]
  • Subgroup analysis of age in the score change from baseline in the MDS-UPDRS part III after 8-week treatment [Срок оценки: evaluation time points: baseline, week 8.]

Критерии участия

Критерии включения

Participants must meet all of the following criteria:

1\. Diagnosed with Parkinson's disease (PD) according to the 2016 Chinese 2. Diagnostic Criteria for Parkinson's Disease.

3\. Hoehn-Yahr stage <3 (mild to moderate PD). 4. Age between 30 and 80 years (inclusive). 5. Signed informed consent indicating voluntary participation.

Критерии исключения

Participants meeting any of the following criteria will be excluded:

  • Diagnosed with Parkinson-plus syndromes or other secondary parkinsonism.
  • Prior history of deep brain stimulation (DBS) surgery.
  • Severe cerebrovascular disease, brain trauma, or history of craniotomy.
  • Severe dementia or psychiatric disorders that prevent cooperation with study procedures.
  • Severe coagulation disorders.
  • Presence of severe systemic organ dysfunction (cardiac, pulmonary, hepatic, renal, endocrine, or metabolic disorders).
  • Pregnant or breastfeeding women.
  • History of allergic reaction to acupuncture or moxibustion.
  • Prior treatment with acupuncture or moxibustion within the past three months.
  • Participation in another clinical trial within the past three 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
Четверное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Guang'anmen Hospita, China Academy of Chinese Medical Sciences — Пекин

Идентификаторы

NCT: NCT06874803 · HLCMHPP2023003

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗