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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:
A total of 38 participants were randomly allocated into two groups, either PN or Sham PN needle groups
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | The press needle and medication |
|
| Control Group | Sham Comparator | The sham press needle and medication |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria Anastasia Darmawan, MD | Contact | +6281310875596 | maria.darmawan@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| KPEK FKUI-RSCM | The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitas Indonesia | Recruiting | Jakarta Pusat | DKI Jakarta | 10430 | Indonesia |
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| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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The intervention group received press needles and medication, while the control group received sham press needles and medication.
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The participants and the outcome asssesors will be blinded to group allocation
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| 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 |
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