Functional DyspepsiaNCT07210294
Press Needle on Body Acupuncture Points and Auricular Acupuncture Points on Functional Dyspepsia
A study testing The press needle and medication in people with Functional Dyspepsia, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- The press needle and medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteIndonesia
- Study dates
- 28 Aug 2025to 6 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430
Maria Anastasia Darmawan, MD, +6281310875596, maria.darmawan@gmail.com
About this study
Official title: The Effect of 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:
Read more
- 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
- Being tested
- The press needle and medication, The sham press needle and medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The press needle and medicationDevice
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 medicationDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The press needle and medication Receives: Device: The press needle and medication |
| Control Group | Sham comparator | The sham press needle and medication Receives: Device: The sham press needle and medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Before therapy, day 7, day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start28 Aug 2025
- Primary completion6 Jul 2026 (estimated)
- Study completion6 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The intervention group received press needles and medication, while the control group received sham press needles and medication.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Anastasia Darmawan, Universitas Indonesia
- Investigators
- KPEK FKUI-RSCM, Principal investigator, The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210294
- Sponsor's protocol ID
- 25-05-0594
- Status last verified
- Sep 2025
- First submitted
- 29 Sep 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Press Needle on Body Acupuncture Points and Auricular Acupuncture Points on Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT07210294
- Acronym / sponsor ID
- 25-05-0594
- Conditions
- Functional Dyspepsia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 6 Jul 2026 (estimated)
- Study completion
- 6 Jul 2026 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The intervention group received press needles and medication, while the control group received sham press needles and medication.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: The press needle and medicationThe press needle and medication |
| Control Group | Sham comparator | Device: The sham press needle and medicationThe sham press needle and medication |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The press needle and medicationPress 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 | Device | Intervention Group |
| The sham press needle and medicationSham 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 | Device | Control Group |
Primary outcome
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.
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
KPEK FKUI-RSCM principal investigator
The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The press needle and medication in people with Functional Dyspepsia, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Anastasia Darmawan, MD (+6281310875596, maria.darmawan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ) (time frame: Before therapy, day 7, day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.