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

NCT07210294 | Recruiting

• 1 other identifier: 25-05-0594
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (2)

• 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.

  Before therapy, day 7, day 14

• 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)

  Before therapy, day 7, day 14

Study Arms (2)

Intervention Group

EXPERIMENTAL

The press needle and medication

Device: The press needle and medication

Control Group

SHAM COMPARATOR

The sham press needle and medication

Device: The sham press needle and medication

Interventions

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

Intervention Group

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

Control Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

MeSH Terms

Interventions

Dosage Forms

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• KPEK FKUI-RSCM

  The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Anastasia Darmawan, MD

CONTACT

+6281310875596; maria.darmawan@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and the outcome asssesors will be blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: The intervention group received press needles and medication, while the control group received sham press needles and medication.

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: October 7, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): July 6, 2026
• Study Completion (Estimated): July 6, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)