Press Needle on Body Acupuncture Points and Auricular Acupuncture Points on Functional Dyspepsia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The press needle and medication, The sham press needle and medication.
- Who it may be relevant to
- Registry conditions: Functional Dyspepsia. Basic parameters: 18 years — 59 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Indonesia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Press Needle on Body Acupuncture Points and Auricular Acupuncture Points on Functional Dyspepsia
Overview
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.
Interventions
- Device 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 - Device 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
Primary outcome measures
- Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) [Time frame: Before therapy, day 7, day 14]
- Short-Form Nepean Dyspepsia Index (SF-NDI) [Time frame: Before therapy, day 7, day 14]
Eligibility criteria
Inclusion criteria
- 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).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Indonesia · 1 center
- Universitas Indonesia — Jakarta Pusat
Identifiers
NCT: NCT07210294 · 25-05-0594