Sphenopalatine Ganglion Acupuncture for Allergic Rhinitis

NCT07784491 | Not Yet Recruiting DMC

• 1 other identifier: KY-2026-030
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Allergic Rhinitis

Keywords

Sphenopalatine Ganglion; Allergic Rhinitis; Intranasal Corticosteroid

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Total Nasal Symptom Score

  Baseline, Week 2, Week 4, Week 8 and Month 6.

Secondary Outcomes (3)

• Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire Score

  Baseline, Week 2, Week 4, Week 8 and Month 6

• Total Non-Nasal Symptom Score

  Baseline, Week 2, Week 4, Week 8 and Month 6.

• Change From Baseline in Nasal Examination Score

  Baseline and Week 4.

Other Outcomes (3)

• Number of Days of Rescue Medication Use

  During the 4-week treatment period

• Change From Baseline in Peripheral Blood Eosinophil Count

  Baseline and Week 4

• Incidence of Treatment-Emergent Adverse Events

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

Study Arms (3)

Intranasal Corticosteroid Group

ACTIVE COMPARATOR

Participants assigned to this group will receive intranasal corticosteroid treatment alone for 4 weeks.

Drug: Mometasone furoate nasal spray

Sphenopalatine Ganglion Acupuncture Group

EXPERIMENTAL

Participants assigned to this group will receive sphenopalatine ganglion acupuncture alone for 4 weeks.

Procedure: Sphenopalatine Ganglion Acupuncture

Combination Group

EXPERIMENTAL

Participants assigned to this group will receive sphenopalatine ganglion acupuncture combined with intranasal corticosteroid treatment for 4 weeks.

Procedure: Sphenopalatine Ganglion Acupuncture; Drug: Mometasone furoate nasal spray

Interventions

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.

Also known as: Pterygopalatine Ganglion Acupuncture

Combination Group; Sphenopalatine Ganglion Acupuncture Group

Mometasone furoate nasal spray DRUG

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

Also known as: Intranasal Corticosteroid

Combination Group; Intranasal Corticosteroid Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Torch Development Zone People's Hospital: lead

Study Sites (1)

Zhongshan Torch Development Zone People's Hospital

Zhongshan, Guangdong, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Junling Li

CONTACT

+8613189264696; junlingli26@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 20, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 3-5 years
• Access Criteria: Data may be made available to qualified researchers upon reasonable request for scientifically sound research purposes, subject to approval by the principal investigator and the participating institution, and in accordance with applicable ethical and data protection requirements.

Locations

CN (1)