Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:23 AM
Study NCT ID:
NCT07210294
Status:
RECRUITING
Last Update Posted:
2025-10-07
First Post:
2025-09-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Press Needle on Body Acupuncture Points and Auricular Acupuncture Points on Functional Dyspepsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004304', 'term': 'Dosage Forms'}], 'ancestors': [{'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The participants and the outcome asssesors will be blinded to group allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'The intervention group received press needles and medication, while the control group received sham press needles and medication.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-07-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2025-09-29', 'studyFirstSubmitQcDate': '2025-09-29', 'lastUpdatePostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short-Form Leeds Dyspepsia Questionnaire (SF-LDQ)', 'timeFrame': 'Before therapy, day 7, day 14', 'description': '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.'}, {'measure': 'Short-Form Nepean Dyspepsia Index (SF-NDI)', 'timeFrame': 'Before therapy, day 7, day 14', 'description': '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)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Functional Dyspepsia']}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions this study aims to answer are:\n\n* 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?\n* 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?\n\nA total of 38 participants were randomly allocated into two groups, either PN or Sham PN needle groups\n\nParticipants will:\n\n* Receive PN or Sham PN for 14 days and replaced on day 7.\n* Complete the SF-LDQ and SF-NDI questionnaires before therapy, on day 7, and day 14.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '59 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18-59 years\n* Patients with functional dyspepsia\n* Esophagogastroduodenoscopy (EGD) results show no significant structural abnormalities or no structural abnormalities.\n* Willing to participate in the research until completion and sign a letter of consent for medical action (informed consent).\n\nExclusion Criteria:\n\n* At the acupuncture point location there is inflammation, malignancy, and scar tissue.\n* Deformity of the earlobe.\n* History of allergies to stainless steel and plaster.\n* Medical emergencies, impaired consciousness, pregnancy, history of diabetes mellitus, and history of keloid formation.\n* History of digestive tract cancer, history of hepatobiliary cancer, history of chronic kidney failure stage 4 and 5, history of hyperthyroidism or hypothyroidism.'}, 'identificationModule': {'nctId': 'NCT07210294', 'briefTitle': 'Press Needle on Body Acupuncture Points and Auricular Acupuncture Points on Functional Dyspepsia', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Effect of Press Needle on Body Acupuncture Points and Auricular Acupuncture Points on Functional Dyspepsia', 'orgStudyIdInfo': {'id': '25-05-0594'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'The press needle and medication', 'interventionNames': ['Device: The press needle and medication']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'The sham press needle and medication', 'interventionNames': ['Device: The sham press needle and medication']}], 'interventions': [{'name': 'The press needle and medication', 'type': 'DEVICE', 'description': '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).\n\nMedication using proton pump inhibitor drugs', 'armGroupLabels': ['Intervention Group']}, {'name': 'The sham press needle and medication', 'type': 'DEVICE', 'description': '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).\n\nMedication using proton pump inhibitor drugs', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'status': 'RECRUITING', 'country': 'Indonesia', 'contacts': [{'name': 'Maria Anastasia Darmawan, MD', 'role': 'CONTACT', 'email': 'maria.darmawan@gmail.com', 'phone': '+6281310875596'}], 'facility': 'Universitas Indonesia', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'centralContacts': [{'name': 'Maria Anastasia Darmawan, MD', 'role': 'CONTACT', 'email': 'maria.darmawan@gmail.com', 'phone': '+6281310875596'}], 'overallOfficials': [{'name': 'KPEK FKUI-RSCM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Maria Anastasia Darmawan', 'investigatorAffiliation': 'Indonesia University'}}}}