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Идёт набор NCT06782815

Acupoint Selection Based on Meridian Theory in Primary Insomnia of Liver Depression and Spleen Deficiency Type

Без фазы С лечением Primary Insomnia

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, Acupuncture.
Кому может быть актуально
Состояния в реестре: Primary Insomnia. Базовые параметры: 18 лет — 40 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
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Официальное название

Study on the Curative Effect and Autonomic Nerve Function of Primary Insomnia Patients with Liver Depression and Spleen Deficiency Type Based on Acupoint Selection of Meridian Theory

Обзор

The classical literature combined with modern medicine to select acupoints, in order to intervene in the autonomic nerve function of the superior cervical sympathetic ganglion as an opportunity, put forward the meridian acupoints mainly to reconcile the head orifices Ying Wei, acupuncture treatment of primary insomnia clinical research. Heart rate variability ( HRV ), Pittsburgh sleep quality index ( PSQI ), polysomnography ( PSG ) and the MOS item short from health survey ( SF-36 ) were observed. Insomnia Severity Index ( ISI ), Dysfunctional Beliefs and Attitudes about Sleep Scale 16 ( DBAS-16 ), GABA, Glx and other secondary indicators were used to clarify the clinical short-term and long-term efficacy of different acupoints in the treatment of patients with primary insomnia and the intervention effect on HRV.

Подробное описание

In this randomized controlled trial, 96 patients with insomnia of liver depression and spleen deficiency type were selected from the Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine. All patients will be randomly assigned to the control group or the acupuncture group.

MAIN OUTCOME MEASURES : Pittsburgh Sleep Quality Index ( PSQI ) was used to measure sleep quality, and 36-Item Short Form Health Survey ( SF-36 ) was used to measure quality of life. Secondary outcomes included the Insomnia Severity Index ( ISI ), Sleep Dysfunction Beliefs and Attitudes Scale 16, DBAS-16, GABA and Glx.

Вмешательства

  • Устройство Acupuncture
    acupuncture Baihui, Sishencong ; acupuncture bilateral Qimen, Zhangmen, Hegu, Taichong, reinforcing and reducing, until the acid swelling is obvious,stopped ferforming acupuncture, the needle was retained for 30 min.
  • Устройство Acupuncture
    （1）Acupuncture bilateral Tianrong points, obliquely 45 ± 5 ° backward, 1-1.5 inch deep, reinforcing and reducing horizontally, and stop the needle when the auricle has a heat sensation ; （2）Acupuncture at bilateral Tianyou points, pointing to the tip of the nose, with a depth of 0.5-1 inches, flat reinforcing and reducing, until the sense of soreness and distension obviously stops, and the needle is retained for 30 minutes.

Первичные конечные точки

  • Sleep quality measured by Pittsburgh sleep quality index ( PSQI) [Срок оценки: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.]
  • Quality of life measure by 36-item short form health survey（SF-36） [Срок оценки: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.]
Вторичные конечные точки (4)
  • Insomnia Severity Index（ISI） [Срок оценки: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.]
  • Dysfunctional Beliefs and Attitudes about Sleep Scale 16，DBAS-16 (DBAS-16) [Срок оценки: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.]
  • GABA [Срок оценки: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.]
  • Glx [Срок оценки: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.]

Критерии участия

Критерии включения

  • In line with the diagnostic criteria of insomnia of liver depression and spleen deficiency type in traditional Chinese medicine :
  • In line with the Western diagnostic criteria for insomnia ;
  • 18 ≤ age ≤ 40 years old, male or female ;
  • patients with a course of more than two weeks ; Note: The above criteria must be met for inclusion in this study.

Критерии исключения

  • Insomnia caused by a variety of organic diseases, neurological or psychiatric disorders
  • Pregnancy, lactation or drug allergy
  • There are more serious primary diseases such as cardiovascular and cerebrovascular diseases, gastrointestinal diseases, endocrine system diseases, or psychiatric patients.
  • Patients with coagulation dysfunction and bleeding tendency.

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

Китай · 1 центр
  • The Third Affiliated Hospital of Zhejiang Chinese Medical University — Ханчжоу

Идентификаторы

NCT: NCT06782815 · 2024ZL531-primary insomnia

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗