protocolSection identificationModule nctId: NCT06323304, orgStudyIdInfo id: 701/HDDD-DHYD, briefTitle: Efficacy and Safety of Auricular Acupressure in Treating Allergic Rhinitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-13, primaryCompletionDateStruct date: 2024-06, completionDateStruct date: 2024-06, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: University of Medicine and Pharmacy at Ho Chi Minh City, class: OTHER, descriptionModule briefSummary: Allergic rhinitis (AR) is a global health problem affecting approximately 10% to 40% of the population worldwide, with an increasing trend. It significantly impacts health and quality of life. Current treatments for AR include allergen avoidance, symptom-relieving medications, anti-inflammatory therapy, and allergen-specific immunotherapy. However, many patients still experience uncontrolled symptoms despite these approaches, either as monotherapy or in combination, along with medication side effects such as drowsiness, dry eyes, nasal mucosal damage, and immunosuppression.Auricular acupressure therapy (AAT) utilizes ear acupoints by applying pressure with ear seeds. The neurobiological mechanisms of AAT on the human body have gained increasing attention in clinical and experimental studies, involving anti-inflammatory, antioxidant, and immunomodulatory effects. Its efficacy has been recognized, becoming a potential alternative therapy for various conditions such as sleep disorders, obesity, and chronic pain. Previous clinical studies have reported the efficacy and safety of AAT in treating AR. However, the primary outcomes of these studies remain inconsistent and lack specific criteria for evaluating AR treatment efficacy.This study aims to investigate the efficacy and safety of AAT in treating AR based on the ARIA guideline 2019 treatment efficacy criteria. It will provide a basis for applying AAT as a complementary approach in the multimodal treatment of AR., conditionsModule conditions: Itching, conditions: Runny Nose, conditions: Sneezing, conditions: Nasal Congestion, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Triple-blind method (Participant, Investigator, Outcome assessor) Participants will be blinded to their randomization assignment, either to the intervention group or the control group. Sham acupressure therapy will be performed at acupoints that have no therapeutic effect on allergic rhinitis, and the procedures will be similar to auricular pressure therapy. Both groups will be treated with fluticasone propionate nasal spray, which is the standard treatment.The physician who perform auricular acupressure therapy or sham acupressure therapy will be aware of the intervention assignment for each group, but they will not be involved in data analysis or outcome assessment. The data analysts and outcome assessors will be blinded to the treatment assignment., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Auricular acupressure, interventions name: Sham acupressure, interventions name: Standard treatment, outcomesModule primaryOutcomes measure: The change of nasal and non nasal symptom scores, secondaryOutcomes measure: The change of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, secondaryOutcomes measure: The change of relief medication usage, secondaryOutcomes measure: Proportion of intervention-related adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Medical Center HCMC - Branch no.3, status: RECRUITING, city: Ho Chi Minh, zip: 700000, country: Vietnam, contacts name: Chau Ngoc Le, MD, role: CONTACT, phone: +84942831722, email: lnchau.ntyhct21@ump.edu.vn, contacts name: Minh-Man Pham Bui, MD, role: CONTACT, phone: +84916080803, email: bpmman@ump.edu.vn, geoPoint lat: 10.82302, lon: 106.62965, hasResults: False