Sphenopalatine Ganglion Acupuncture for Allergic Rhinitis

N/ANot Yet RecruitingNCT07784491

Zhongshan Torch Development Zone People's Hospital150 enrolled

Overview

Allergic rhinitis can cause sneezing, a runny or blocked nose, and nasal itching, which may affect daily activities and quality of life. Nasal corticosteroid sprays are commonly used to control these symptoms, but some people may still have bothersome symptoms. The purpose of this study is to find out whether adding sphenopalatine ganglion acupuncture to mometasone furoate nasal spray can improve allergic rhinitis symptoms more than using the nasal spray alone, and to evaluate the safety of this treatment. Adults with moderate-to-severe perennial allergic rhinitis will be randomly assigned to one of two treatment groups. Both groups will use mometasone furoate nasal spray for 4 weeks. Participants in one group will also receive sphenopalatine ganglion acupuncture twice a week for 4 weeks. Researchers will compare changes in nasal symptoms, quality of life, use of rescue medication, clinical examination findings, and adverse events between the two groups. Participants will also be followed after treatment to assess whether the treatment effects are maintained.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Allergic Rhinitis

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

* Inclusion Criteria: * Diagnosis of allergic rhinitis according to the Chinese Guidelines for Diagnosis and Treatment of Allergic Rhinitis (2022 Revision), meeting all of the following criteria: * At least two of the following symptoms: paroxysmal sneezing, watery rhinorrhea, nasal itching, and nasal obstruction, with symptoms lasting or accumulating for at least 1 hour per day; ocular symptoms such as itching, tearing, or redness may also be present. * Anterior rhinoscopy or nasal endoscopy showing findings consistent with allergic rhinitis, such as pale or edematous nasal mucosa, turbinate swelling, and watery nasal secretions. * At least one positive allergen test, including a skin prick test, serum allergen-specific immunoglobulin E (sIgE) test, or nasal allergen provocation test. * No use of antihistamines, intranasal or systemic corticosteroids, leukotriene receptor antagonists, allergen immunotherapy, or other treatments that may affect efficacy assessment within 2 weeks before enrollment. * Baseline Total Nasal Symptom Score (TNSS) sufficient for efficacy assessment according to the study protocol. * Voluntary participation in the study and provision of written informed consent. * Exclusion Criteria: * Presence of acute upper respiratory tract infection, acute or chronic rhinosinusitis, nasal polyps, severe nasal septal deviation, rhinitis medicamentosa, vasomotor rhinitis, infectious rhinitis, or other forms of non-allergic rhinitis. * Presence of an autoimmune disease or a psychiatric or psychological disorder that may interfere with study participation or outcome assessment. * Pregnancy or breastfeeding. * Coagulation disorders, current use of anticoagulant medications, local skin infection at the acupuncture site, a tendency to develop excessive scarring, or inability to tolerate acupuncture. * Known severe hypersensitivity or contraindication to any component of the study medication or to the study intervention. * Current participation in another clinical study, or any other condition that, in the investigator's judgment, makes the participant unsuitable for this study.

Outcomes

Primary Outcomes

Change From Baseline in Total Nasal Symptom Score

Time frame: Baseline, Week 2, Week 4, Week 8 and Month 6.

Secondary Outcomes

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire Score

Time frame: Baseline, Week 2, Week 4, Week 8 and Month 6

Total Non-Nasal Symptom Score

Time frame: Baseline, Week 2, Week 4, Week 8 and Month 6.

Change From Baseline in Nasal Examination Score

Time frame: Baseline and Week 4.