The Effect of Press Needle on Body Acupuncture Points and Auricular Acupuncture Points on Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The participants and the outcome asssesors will be blinded to group allocation
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
Intervention Group
The press needle and medication
干预措施: The press needle and medication (Device)
Control Group
The sham press needle and medication
干预措施: The sham press needle and medication (Device)
结局指标
主要结局
Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ)
时间窗: Before therapy, day 7, day 14
Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) is a questionnaire consisting of 4 questions A and B. The total score ranges from 0 to 32.
Short-Form Nepean Dyspepsia Index (SF-NDI)
时间窗: Before therapy, day 7, day 14
Short-Form Nepean Dyspepsia Index (SF-NDI) is a questionnaire consisting of 10 questions. The total score ranges from 10 to 50 (higher score indicate worst quality of life)
次要结局
未报告次要终点
研究者
Maria Anastasia Darmawan
MD
Indonesia University