Press Needle on Body Acupuncture Points and Auricular Acupuncture Points on Functional Dyspepsia

Официальное название

The Effect of Press Needle on Body Acupuncture Points and Auricular Acupuncture Points on Functional Dyspepsia

Обзор

The aim of this study was to prove that press needle (PN) and medication are more effective in reducing symptoms and improving quality of life in people with functional dyspepsia compared to sham press needle (Sham PN) and medication. The main questions this study aims to answer are: * Does the press needle and medication group reduce symptoms in people with functional dyspepsia as assessed by the Short Form-Leeds Dyspepsia Questionnaire (SF-LDQ) compared to the sham press-needle and medication group on days 7 and 14, compared to before therapy? * Does the press-needle and medication group improve quality of life in people with functional dyspepsia as assessed by the Short-Form Nepean Dyspepsia Index (SF-NDI) compared to the sham press-needle and medication group on days 7 and 14, compared to before therapy? A total of 38 participants were randomly allocated into two groups, either PN or Sham PN needle groups Participants will: * Receive PN or Sham PN for 14 days and replaced on day 7. * Complete the SF-LDQ and SF-NDI questionnaires before therapy, on day 7, and day 14.

Вмешательства

• Устройство The press needle and medication
  Press needles using the needle sizes 0.17mm x 0.9mm on auricular acupuncture points (MA-IC6 (Stomach) bilaterally) and the needle sizes 0.20 mm x 1.5mm on body acupuncture points (ST36 bilaterally). After that, apply an adhesive patches on top of the press needle. The press needle is attached for 14 days (on the 7th day the press needle is replaced). Medication using proton pump inhibitor drugs
• Устройство The sham press needle and medication
  Sham press needle uses adhesive patches without needles on auricular acupuncture points (MA-IC6 (Stomach) bilateral) and body acupuncture points (ST36 bilateral). The sham press needle is attached for 14 days (on the 7th day the sham press needle is replaced). Medication using proton pump inhibitor drugs

Первичные конечные точки

• Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) [Срок оценки: Before therapy, day 7, day 14]
• Short-Form Nepean Dyspepsia Index (SF-NDI) [Срок оценки: Before therapy, day 7, day 14]

Критерии участия

Критерии включения

• Male or female aged 18-59 years
• Patients with functional dyspepsia
• Esophagogastroduodenoscopy (EGD) results show no significant structural abnormalities or no structural abnormalities.
• Willing to participate in the research until completion and sign a letter of consent for medical action (informed consent).

Критерии исключения

• At the acupuncture point location there is inflammation, malignancy, and scar tissue.
• Deformity of the earlobe.
• History of allergies to stainless steel and plaster.
• Medical emergencies, impaired consciousness, pregnancy, history of diabetes mellitus, and history of keloid formation.
• History of digestive tract cancer, history of hepatobiliary cancer, history of chronic kidney failure stage 4 and 5, history of hyperthyroidism or hypothyroidism.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Universitas Indonesia — Jakarta Pusat

Идентификаторы

NCT: NCT07210294 · 25-05-0594

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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