Recruiting

Press Needle for Functional Dyspepsia Relief

What is being tested

The press needle and medication

+ The sham press needle and medication

Device

Who is being recruted

From 18 to 59 Years

+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled

Interventional

Study Start: August 2025

See protocol details

Summary

Principal SponsorIndonesia University

Study ContactMaria Anastasia Darmawan, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: August 28, 2025

Actual date on which the first participant was enrolled.

This clinical trial explores the effectiveness of using press needles, a form of acupuncture, combined with medication to treat functional dyspepsia, a common digestive disorder causing discomfort in the upper abdomen. The study targets individuals suffering from this condition, aiming to determine whether this combination can better alleviate symptoms and enhance the quality of life compared to using a sham or placebo version of the needles alongside medication. This research is important as it seeks to offer a potentially more effective treatment option for those experiencing the discomfort of functional dyspepsia. Participants in the study are divided into two groups: one receiving the actual press needle treatment and the other receiving a sham version, both alongside medication. Over a period of 14 days, participants receive either the real or sham needles, which are replaced after 7 days. To measure the effectiveness, participants complete questionnaires designed to assess their symptoms and quality of life before starting the treatment, halfway through, and at the end of the trial. This helps determine how well each treatment approach works, providing valuable insights into managing functional dyspepsia. There are no specific risks mentioned, making it a safe exploration of treatments for participants.

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

NCT07210294

Principal SponsorIndonesia University

Study ContactMaria Anastasia Darmawan, MD

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

38 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 59 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate

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).

5 exclusion criteria prevent from participating

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

The press needle and medication

Group II

Sham

The sham press needle and medication

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Universitas Indonesia

Jakarta Pusat, IndonesiaOpen Universitas Indonesia in Google Maps

Recruiting

One Study Center