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RecruitingNCT07210294Updated Oct 7, 2025

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

An interventional study of The press needle and medication and The sham press needle and medication in Functional Dyspepsia, sponsored by Indonesia University. Recruiting at 1 site in Indonesia. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2025-10-07.

Sponsored by Indonesia University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Aug 2025; still recruiting 1 year 1 month later.
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

Study summary

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.
02

Conditions studied

  • Functional Dyspepsia
03

In context

Lead sponsor

Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
38 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    The press needle and medication

    Device: The press needle and medication

  • Sham comparator
    Control Group

    The sham press needle and medication

    Device: The sham press needle and medication

Interventions

  • DeviceThe 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

  • DeviceThe 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

06

What researchers measure

Primary outcomes

  1. Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ)

    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.

    Time frame: Before therapy, day 7, day 14

  2. Short-Form Nepean Dyspepsia Index (SF-NDI)

    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)

    Time frame: Before therapy, day 7, day 14

07

Study locations

1 of 1 sites recruiting
  • Universitas Indonesia
    Jakarta Pusat, DKI Jakarta 10430, Indonesia
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07210294
Lead sponsor
Indonesia University
Responsible party
Maria Anastasia Darmawan (MD, Indonesia University) — Principal investigator
First posted
Oct 7, 2025
Start date
Aug 28, 2025
Primary completion
Jul 6, 2026 (estimated)
Completion
Jul 6, 2026 (estimated)
Last update
Oct 7, 2025

Study contacts

Maria Anastasia Darmawan, MD
Contact
maria.darmawan@gmail.com
+6281310875596
KPEK FKUI-RSCM
principal investigator · The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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