Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT04815668

Acupuncture at the Sphenopalatine Ganglion in the Treatment of Moderate-to-severe Seasonal Allergic Rhinitis

Led by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Updated on 2025-07-16

120

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

Sponsors

G

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Lead Sponsor

A

Aerospace 731 Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Allergic rhinitis (AR) is an immunoglobulin E-mediated inflammatory disease1 caused by hypersensitivity of the immune system to an allergen, affecting 100 million people in Europe 2and 400 million of the global population.The etiology of AR is multifactorial, resulting primarily from genetic predisposition, immunological response, and environmental pollutants.AR traditionally has been classified as seasonal (SAR) or perennial (PAR) depending on the causes and duration of symptoms. Some patients with AR prefer complementary and alternative medicine for their symptoms, with nearly 20% receiving acupuncture. According to the updated practice parameter of rhinitis in 2020, the use of acupuncture for the treatment of AR was not recommended due to a lack of well-controlled studies. The sphenopalatine ganglion (SPG), located under a thin (1-2 mm) layer of mucosa in the pterygopalatine fossa, consists of sensory fibers that innervate the nasopharynx, nasal cavity, and palate.Several studies have reported the benefit of SPG stimulation in chronic cluster headache and acute ischaemic stroke. Compared with traditional acupoints selected on basis of traditional meridian theory, acupuncture at SPG(inserting a needle through SPG acupoint (near ST7, Xiaguan) to reach and directly stimulate the SPG) may help patients ameliorate nasal symptoms immediately and improve quality of life by increasing sympathetic nerve excitability, but the evidence is inconclusive. We have designed this three-armed, randomized trial to investigate the efficacy and safety of acupuncture at SPG for the treatment of SAR. We hypothesize that acupuncture at SPG plus rescue medication is superior to sham acupuncture plus RM and RM alone in the treatment of SAR.

CONDITIONS

Official Title

Acupuncture at the Sphenopalatine Ganglion in the Treatment of Moderate-to-severe Seasonal Allergic Rhinitis

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older and 75 years or younger
  • History of moderate to severe seasonal allergic rhinitis symptoms for more than 4 days per week and at least 4 consecutive weeks for at least 2 years
  • Positive skin prick test to grass and birch pollen or serum-specific IgE test
  • Ability to complete medical information form and give written informed consent
Not Eligible

You will not qualify if you...

  • History or current evidence of perennial allergic rhinitis, acute sinusitis, allergic asthma, pneumonia, autoimmune disorders, or severe chronic inflammatory diseases
  • History of nasal rhinopolypus or abnormalities
  • Use of antihistamines, anticholinergics, corticosteroids, decongestants, or antibiotics within 1 month prior to study start
  • Use of systemic corticosteroids within 6 months or allergy immunotherapy within 1 year before enrollment
  • Serious uncontrolled blood clotting issues, cardiovascular disease, severe liver or kidney problems, or mental disorders
  • Pregnancy or planning pregnancy
  • Known allergy or contraindication to rescue medication or related drugs
  • Fear of acupuncture or prior acupuncture, sphenopalatine ganglion stimulation, or other alternative medicine treatments within 1 month before enrollment

AI-Screening

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Trial Site Locations

Total: 1 location

1

No.731 Hospital of China Aerospace Science and Industry Corporation

Beijing, China

Actively Recruiting

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Research Team

W

Weiming Wang, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Acupuncture at the Sphenopalatine Ganglion in the Treatment of Moderate-to-severe Seasonal Allergic Rhinitis | DecenTrialz