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NCT Number: NCT07784491

Sphenopalatine Ganglion Acupuncture for Allergic Rhinitis

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.

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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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.

Treatment and study plan

Sphenopalatine ganglion acupuncture

Procedure

Sphenopalatine ganglion acupuncture will be performed twice weekly for 4 consecutive weeks, for a total of 8 treatment sessions. Acupuncture will be performed alternately on the left and right sides without needle retention.

Other names: Pterygopalatine Ganglion Acupuncture

Mometasone Furoate Nasal spray

Drug

Mometasone furoate nasal spray will be administered as two sprays into each nostril once daily for 4 consecutive weeks.

Other names: Intranasal Corticosteroid

Primary outcomes

  1. Change From Baseline in Total Nasal Symptom Score

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

Secondary outcomes

  1. Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire Score

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

  2. Total Non-Nasal Symptom Score

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

  3. Change From Baseline in Nasal Examination Score

    Time frame: Baseline and Week 4.

Other outcomes

  1. Number of Days of Rescue Medication Use

    Time frame: During the 4-week treatment period

    The total number of calendar days on which each participant uses at least one dose of protocol-permitted rescue medication during the 4-week treatment period will be recorded.

  2. Change From Baseline in Peripheral Blood Eosinophil Count

    Time frame: Baseline and Week 4

    Peripheral blood eosinophil count will be measured at baseline and Week 4. Change from baseline will be calculated as the Week 4 value minus the baseline value.

  3. Incidence of Treatment-Emergent Adverse Events

    Time frame: From randomization through the end of study follow-up, up to 6 months

    The number and proportion of participants experiencing adverse events during the study will be recorded. Acupuncture-related adverse events may include local pain, subcutaneous bleeding or hematoma, dizziness or fainting during acupuncture, needle-related complications, discomfort during mouth opening or chewing, gingival or maxillary discomfort, epistaxis, and local infection. Drug-related adverse events may include nasal dryness, epistaxis, throat discomfort, dry mouth, dizziness, rash, and other allergic reactions. The severity, management, outcome, and relationship of each adverse event to the study intervention will be assessed.

Study contacts

Contact information is provided by the study sponsor or research team.

Junling Li

CONTACT

[email protected]

+8613189264696

Sponsors and collaborators

Lead sponsor

Zhongshan Torch Development Zone People's Hospital

Other

Registry information

Official study title

Sphenopalatine Ganglion Acupuncture for Allergic Rhinitis: A Prospective Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Aug 25, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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