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

Not Applicable

Recruiting

• Conditions: Functional Dyspepsia

• Registration Number: NCT07210294
• Lead Sponsor: Indonesia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-08-28
• Status Verified: 2025-09
• Study First Submitted: 2025-09-29
• Study First Submitted QC: 2025-09-29
• Last Update Submitted: 2025-09-29
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Primary Completion: 2026-07-06
• Study Completion: 2026-07-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ)	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)	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)

Trial Locations

Locations (1)

Universitas Indonesia; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia