Evaluation of the Efficacy of Electroacupuncture in the Treatment of Functional Dyspepsia

Официальное название

Evaluation of the Efficacy of Electroacupuncture in the Treatment of Functional Dyspepsia: A Pilot Study

Обзор

Brief Summary Template for the Study: The goal of this clinical trial is to evaluate whether electroacupuncture can treat functional dyspepsia (FD) in adult participants aged 18 to 65 years, including both males and females, who have been diagnosed with functional dyspepsia based on the Rome IV criteria. The main questions it aims to answer are: * Does 5 Hz electroacupuncture improve symptoms in functional dyspepsia patients? * Does 100 Hz electroacupuncture improve symptoms in functional dyspepsia patients? * Are there differences in the efficacy between 5 Hz and 100 Hz electroacupuncture in treating functional dyspepsia and its subtypes (PDS and EPS)? Researchers will compare the effects of 5 Hz electroacupuncture, 100 Hz electroacupuncture, and sham electroacupuncture to determine which approach provides more significant symptom relief and whether different frequencies have varying impacts on FD subtypes. Participants will: * Receive electroacupuncture treatment at specific acupoints (such as Liangmen, Tianshu, Zusanli, and Xiajuxu) for 30-minute sessions, 3 times a week for 4 weeks. * Be randomly assigned to one of the following groups: 5 Hz electroacupuncture, 100 Hz electroacupuncture, or sham electroacupuncture (control). * Have their functional dyspepsia symptoms, quality of life, and any adverse effects monitored and evaluated throughout the study.

Вмешательства

• Другое 5 Hz electroacupuncture
  Intervention Description: The intervention in this study involves the use of electroacupuncture (EA), a combination of traditional acupuncture and electrical stimulation. Acupoints Selection: Electroacupuncture will be performed at specific acupoints associated with the stomach and digestive system. The local acupoints chosen are Liangmen (ST21) and Tianshu (ST25), while the distal acupoints are Zusanli (ST36) and Xiajuxu (ST39). This selection is based on Traditional Chinese Medicine (TCM) pr
• Другое Sham electroacupuncture
  Participants will receive sham electroacupuncture at the same acupoints: Liangmen (ST21), Tianshu (ST25), Zusanli (ST36), and Xiajuxu (ST39). Non-penetrating needles will touch the skin but will not induce \"deqi.\" A sham electroacupuncture device (no actual current) will be used, and treatment will last 30 minutes per session. Participants will receive 3 sessions per week for 4 weeks (total: 12 sessions). This arm serves as a placebo control to evaluate the true effect of electroacupun
• Другое 100 Hz electroacupuncture
  Intervention Description: The intervention in this study involves the use of electroacupuncture (EA), a combination of traditional acupuncture and electrical stimulation. Acupoints Selection: Electroacupuncture will be performed at specific acupoints associated with the stomach and digestive system. The local acupoints chosen are Liangmen (ST21) and Tianshu (ST25), while the distal acupoints are Zusanli (ST36) and Xiajuxu (ST39). This selection is based on Traditional Chinese Medicine (TCM) pr

Первичные конечные точки

• Symptom Improvement Rate at Week 4 [Срок оценки: 4 weeks after the start of treatment.]
• Main Symptom Resolution Rate at Week 4 [Срок оценки: 4 weeks after the start of treatment.]

Вторичные конечные точки (5)

• Global Overall Symptom (GOS) Score Change [Срок оценки: Baseline to Week 4]
• Nepean Dyspepsia Index (NDI) Score Change [Срок оценки: Baseline to Week 4]
• Hospital Anxiety and Depression Scale (HADS) Score Change [Срок оценки: Baseline to Week 4]
• Treatment Expectation Score [Срок оценки: Prior to the first treatment (Baseline)]
• Blind evaluation [Срок оценки: immediately after 1st and 6th treatment sessions]

Критерии участия

Критерии включения

• Diagnosed with functional dyspepsia based on Rome IV diagnostic criteria.
• Aged 18 to 80 years, inclusive, with no gender restrictions.
• Normal endoscopy results within the past year, showing no structural explanation for symptoms.
• No acupuncture treatment in the last month.
• Not participating in any other clinical trials in the past 2 months.
• Able to understand and provide informed consent.

Критерии исключения

• Presence of serious or malignant diseases (e.g., cirrhosis, heart failure, gastrointestinal tumors) that could explain dyspepsia symptoms.
• Positive for Helicobacter pylori infection based on C-13 urea breath test or gastric biopsy.
• History of gastrointestinal surgery (excluding laparoscopic and other minimally invasive surgeries).
• Recent use (within 2 weeks) of medications affecting dyspepsia, including prokinetics, proton pump inhibitors, antacids, or antidepressants.
• Presence of severe mental or physical conditions, such as dementia or illiteracy, that could interfere with study participation.
• Severe coagulation disorders.
• Substance abuse or alcohol dependence.
• Pregnant or breastfeeding women.

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 · 4 центра

• The Third Affiliated Hospital of Zhejiang Chinese Medicinal University — Ханчжоу
• Hangzhou First People's Hospital — Ханчжоу
• Sir Run Run Shaw Hospital, affiliated with the Zhejiang University School of Medicine — Ханчжоу
• The First Affiliated Hospital of Zhejiang Chinese Medical University — Ханчжоу

Идентификаторы

NCT: NCT06618911 · 20240903074110247

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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