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

University of Indonesia (UI)

Status: Enrolling

Conditions: Functional Dyspepsia

Treatments: Device: The sham press needle and medication; Device: The press needle and medication

Study type: Interventional

Funder types: Other

Identifiers

NCT07210294

25-05-0594

Details and patient eligibility

About

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.

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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38 participants in 2 patient groups

Intervention Group

Experimental group

Description:

The press needle and medication

Treatment:

Device: The press needle and medication

Control Group

Sham Comparator group

Description:

The sham press needle and medication

Treatment:

Device: The sham press needle and medication