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

NCT ID: NCT07210294

Last Updated: 2025-10-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-28
• Study Completion Date: 2026-07-06

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention Group

The press needle and medication

Group Type: EXPERIMENTAL

The press needle and medication

Intervention Type: 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

Control Group

The sham press needle and medication

Group Type: SHAM_COMPARATOR

The sham press needle and medication

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Maria Anastasia Darmawan

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

KPEK FKUI-RSCM

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status: RECRUITING

Countries

Indonesia

Central Contacts

Maria Anastasia Darmawan, MD

Role: CONTACT

maria.darmawan@gmail.com

+6281310875596

Facility Contacts

Maria Anastasia Darmawan, MD

Role: primary

maria.darmawan@gmail.com

+6281310875596

Other Identifiers

25-05-0594

Identifier Type: -

Identifier Source: org_study_id