Clinical trial NCT06323304: Efficacy and Safety of Auricular Acupressure in Treating Allergic Rhinitis
Official title: Evaluating Efficacy and Safety of Auricular Acupressure in Treating Allergic Rhinitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Itching
Runny Nose
Sneezing
Nasal Congestion
Keywords: Allergic rhinitis
Auricular acupressure therapy
Traditional medicine
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Patients with allergic rhinitis who have typical symptoms such as nasal itching, runny nose, sneezing, nasal congestion, and are indicated for corticosteroid nasal spray according to the ARIA 2019 diagnostic and treatment guidelines will be registered for this study. They will then be randomly assigned to two groups: Intervention group (auricular acupressure therapy + fluticasone propionate nasal spray), and control group (sham auricular acupressure therapy + fluticasone propionate nasal spray). The allocation ratio for the two groups is 1:1.

The intervention period for both groups is four weeks. Auricular acupressure therapy or sham acupressure therapy will be performed every week. Fluticasone propionate nasal spray will be used whenever symptoms occur. Patients will also be encouraged to adjust their lifestyle and living environment.

Data on the severity of allergic rhinitis symptoms (including nasal itching, sneezing, runny nose, nasal congestion, eye symptoms, and headache), the Rhinitis Quality of Life Questionnaire (RQLQ), and side effects of auricular acupressure therapy will be recorded before the study and weekly for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients must be diagnosed with allergic rhinitis according to the ARIA 2019 (Allergic Rhinitis and its Impact on Asthma) diagnostic criteria, must be between 18 and 60 years old.
* Must have had typical symptoms of allergic rhinitis for at least 2 years.
* Must provide written informed consent to participate in the study.
* Must be mentally alert and able to communicate effectively.
* Must have vital signs within normal limits (pulse, blood pressure, temperature, respiratory rate, SpO2).
* Must not have any other chronic diseases, including respiratory diseases (asthma, pneumonia, chronic obstructive pulmonary disease, etc.), thyroid disease, autonomic nervous system disorders, hypertension, or diabetes, as determined by medical history.
* Must not have any knowledge of auricular therapy.

Exclusion Criteria:

* Have used decongestants, antihistamines, anticholinergics, or oral corticosteroids within the past 1 week.
* Have undergone auricular acupuncture, auricular acupressure, or other forms of acupuncture for the treatment of other respiratory diseases within the past 6 months.
* Have used stimulants (alcohol, beer, coffee, tobacco) within 24 hours of the study.
* Lesions (scars, tears, scratches, bites) on the left auricle.
* Allergic rhinitis with secondary infection, acute sinusitis or acute exacerbation of chronic sinusitis, or chronic sinusitis.

Primary outcomes:
measure: The change of nasal and non nasal symptom scores
timeFrame: Assessments were conducted before intervention and after each intervention week throughout the four weeks (Week 0, Week 1, Week 2, Week 3, Week 4)
Secondary outcomes:
measure: The change of Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score
timeFrame: Assessments were conducted before intervention and after each intervention week throughout the four weeks (Week 0, Week 1, Week 2, Week 3, Week 4)
measure: The change of relief medication usage
timeFrame: Assessments were conducted after each intervention week throughout the four weeks (Week 1, Week 2, Week 3, Week 4)
measure: Proportion of intervention-related adverse events
timeFrame: Up to four weeks
Other outcomes:
Locations:
city: Ho Chi Minh
country: Vietnam
facility: University of Medical Center HCMC - Branch no.3
Study officials:
References:
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