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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: May 31, 2024 to Oct 31, 2026
    • Study completion date: Aug 31, 2024 to Dec 31, 2026
    v7
  2. Notable Primary completion date: May 31, 2023 to May 31, 2024
    • Study completion date: Aug 31, 2023 to Aug 31, 2024
    v6
  3. Minor Re-verified, no change to tracked fieldsv5
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v4
  5. Minor Interventions: Acupuncture group (Other), Rescue medication group (Other), Sham acupuncture group (Other) to Acupuncture group (Other), Placebo acupuncture group (Other), Rescue medication group (Other)v3
  6. Minor Re-verified, no change to tracked fieldsv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04815668
Lead Sponsor Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators: Aerospace 731 Hospital
Conditions
(from sponsor)
Seasonal Allergic Rhinitis
Related terms Rhinitis, Allergic, Seasonal
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov