Press-needle acupuncture on body and ear points for functional dyspepsia
The Effect of Press Needle on Body Acupuncture Points and Auricular Acupuncture Points on Functional Dyspepsia
NA · Indonesia University · NCT07210294
This study tests whether adding press-needle acupuncture on body and ear points to usual medication helps adults with functional dyspepsia have fewer symptoms and better quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 38 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | Indonesia University (other) |
| Locations | 1 site (Jakarta Pusat, DKI Jakarta) |
| Trial ID | NCT07210294 on ClinicalTrials.gov |
What this trial studies
Researchers randomized 38 adults with functional dyspepsia and normal endoscopy into two groups to receive either press-needle acupuncture on body and auricular points or a sham press-needle, both alongside standard medication. The press-needles were applied and replaced over a 14-day period. Symptom severity and quality of life were measured with the Short Form–Leeds Dyspepsia Questionnaire (SF-LDQ) and the Short-Form Nepean Dyspepsia Index (SF-NDI) at baseline, day 7, and day 14. The trial tests whether press-needle plus medication provides greater short-term symptom and quality-of-life benefit than sham plus medication.
Who should consider this trial
Good fit: Adults aged 18–59 with functional dyspepsia, normal esophagogastroduodenoscopy results, and willingness to attend in-person treatment in Jakarta are the ideal candidates.
Not a fit: People with structural GI disease, pregnancy, diabetes, advanced kidney disease, metal or plaster allergies, ear deformities, keloid tendency, or other listed exclusions are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, adding press-needle acupuncture could reduce dyspepsia symptoms and improve patients' quality of life beyond medication alone.
How similar studies have performed: Acupuncture for functional dyspepsia has shown mixed but sometimes positive results in prior trials, while press-needle specific evidence is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jakarta Pusat, DKI Jakarta
- Universitas Indonesia — Jakarta Pusat, DKI Jakarta, Indonesia (RECRUITING)
Study contacts
- Principal investigator: KPEK FKUI-RSCM — The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
- Study coordinator: Maria Anastasia Darmawan, MD
- Email: maria.darmawan@gmail.com
- Phone: +6281310875596
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Functional Dyspepsia