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NCT Number: NCT07210294

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

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.

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Key information

Conditions

Functional Dyspepsia

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location status: Recruiting

Location contact

Maria Anastasia Darmawan, MD

CONTACT

[email protected]

+6281310875596

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The press needle and medication

Device

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

The sham press needle and medication

Device

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 outcomes

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

    Time frame: 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.

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

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Anastasia Darmawan, MD

CONTACT

[email protected]

+6281310875596

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 7, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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